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3.0 - 8.0 years
8 - 12 Lacs
Hyderabad, Chennai, Bengaluru
Hybrid
Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : LIMS, GMP, cGMP, Starlims, Labware Lims, Labvantage. The opportunity Were looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills and attributes for success Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills. Interested Candidates can send their Cv's to frichardson@allegisglobalsolutions.com. Regards, Franklin.A
Posted 1 month ago
2.0 - 7.0 years
1 - 2 Lacs
Coimbatore
Work from Office
EXECUTIVE-SALES PPC/-/1306251 Marketing Coimbatore Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 2 years ShareApply Basic Section No. Of Openings 1 Designation Grade Executive M10 Freshers/Experience Experience Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Marketing Country India State Tamil Nadu Region Coimbatore Branch Coimbatore Skills Skill Market and Competitive Analysis Minimum Qualification Any Graduate BSc MBA CERTIFICATION No data available Working Language Tamil English About The Role Candidate taken for the replacement of Mr.N.Sabariyar who is looking in market cirlce-COI02 of Cbe branch.Candiate should be minimum 2-Years experience in marketing and having good knowledge in system.
Posted 1 month ago
0.0 - 1.0 years
0 - 1 Lacs
Mathavaram
Work from Office
Trainee - chemist PPC/T-C/1299164 Warehouse - Quality Madhavaram Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 1 - 1 years ShareApply Basic Section No. Of Openings 2 Designation Grade Executive M10 Freshers/Experience Freshers Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Warehouse - Quality Country India State Tamil Nadu Region Madhavaram Branch Madhavaram Skills Skill Quality Assurance Minimum Qualification BSc CERTIFICATION No data available Working Language English Hindi About The Role To Sample and testing the incoming Raw material, finished goods & Packing material. To inspect in process batch and to test for batch release. To inspect product vessels and provide clearance for production. To develop testing SOP and test methods. To coordinate during external and internal audi ti ng.
Posted 1 month ago
5.0 - 10.0 years
3 - 4 Lacs
Vikarabad, Tandur, Hyderabad
Work from Office
Hello Candidate, Greetings from Hungry Bird IT Consulting Services Pvt. Ltd.! We're hiring a Quality Control Head for our client. Qualification: MSc in Chemistry, Biochemistry, or a related field Location: Vikarabad District, Telangana Experience: 5 to 8 Years Salary: 3.5 lakhs to 4 lakhs per annum Required: Male Note: Preferably with strong experience in the pharmaceutical or ethanol industry. Job Summary: We are seeking an experienced Quality Control Head to lead the QC team at our client's facility. The ideal candidate will have a strong background in analytical techniques, including Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC), and will be responsible for ensuring the highest standards of product quality and regulatory compliance. Responsibilities: Lead, manage, and mentor the Quality Control team. Develop, implement, and oversee all QC procedures and protocols. Supervise analytical testing using GC, HPLC, Spectrophotometer, and other advanced techniques. Ensure all processes and products comply with regulatory requirements and industry standards (e.g., ISO, GMP). Collaborate effectively with production teams to identify and resolve any quality-related issues. Develop and implement robust quality control measures to guarantee final product quality. Train and develop QC team members to enhance their skills and performance. Requirements: Minimum of 5 to 8 years of experience in a Quality Control role. Strong hands-on knowledge of analytical techniques, especially Gas Chromatography (GC) and HPLC. Proven experience with regulatory compliance (e.g., ISO, GMP). Excellent leadership, communication, and problem-solving skills. Proactive, detail-oriented, and able to work in a dynamic environment. (Interested candidates can share their CV to aradhana@hungrybird.in or reach us at 9959417171.) Please furnish the below-mentioned details; that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: RAMESH, QC HEAD, 6 YEARS, 30 DAYS NOTICE Name: Position applying for: Total experience: Notice period: Current Salary: Expected Salary: Thanks and Regards Aradhana +91 9959417171
Posted 1 month ago
3.0 - 5.0 years
3 - 7 Lacs
Dahanu
Work from Office
Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists
Posted 1 month ago
7.0 - 11.0 years
7 - 8 Lacs
Ahmedabad
Work from Office
Job Description Version. no.: The Job Responsibilities of the position holder are : Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19). Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time. Responsible for receiving sample and their documentation. Responsible Data entry in SAP. Responsible for sending the sample to outside laboratory and ensure their analysis as per requirement from Outside Commercial Lab as and when required. Calibration of instruments, as and when required. Preparation of volumetric solution, reagent, and test solution, as and when required. Ensuring the timely updation in the documents as per the Pharmacopeial amendments. Responsible for maintaining the resource in the quality control department. To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. SOP training in Isotrain of self-train within stipulated time. Any other task assigned by reporting manager. In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working. Signatures _____________ Position holder ______________________ Authorized by JOB FAMILY: Operations Quality t
Posted 1 month ago
1.0 - 6.0 years
3 - 8 Lacs
Chandrapur
Work from Office
Dalmia Cement Bharat Ltd is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting analytical data, test results, and laboratory reports to identify deviations or issues and take corrective actions Documentation: Maintaining detailed records of test results, procedures, and observations, as well as preparing reports for documentation and compliance purposes Instrument Maintenance: Calibrating and maintaining laboratory equipment and instruments to ensure accurate and reliable measurements Safety Compliance: Adhering to safety protocols, handling hazardous materials, and ensuring a safe working environment for oneself and others Compliance with Regulations: Ensuring compliance with regulatory standards, safety protocols, and industry-specific guidelines, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) Troubleshooting: Identifying and addressing issues or deviations in chemical processes and recommending corrective actions or process adjustments
Posted 1 month ago
2.0 - 3.0 years
4 - 5 Lacs
Chandrapur
Work from Office
Dalmia Bharat Group is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting analytical data, test results, and laboratory reports to identify deviations or issues and take corrective actions Documentation: Maintaining detailed records of test results, procedures, and observations, as well as preparing reports for documentation and compliance purposes Instrument Maintenance: Calibrating and maintaining laboratory equipment and instruments to ensure accurate and reliable measurements Safety Compliance: Adhering to safety protocols, handling hazardous materials, and ensuring a safe working environment for oneself and others Compliance with Regulations: Ensuring compliance with regulatory standards, safety protocols, and industry-specific guidelines, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) Troubleshooting: Identifying and addressing issues or deviations in chemical processes and recommending corrective actions or process adjustments
Posted 1 month ago
6.0 - 11.0 years
15 - 16 Lacs
Bengaluru
Work from Office
Candidate should hold a Bachelors degree in a computer system, engineer or Technical graduation. 6+ years of working experience in Labware LIMS, Web Services (REST & SOAP) Proficient in all technical aspects of Interfaces development (SAP), LIMS Basics, preferably Labware LIMS, Subroutines, Instrument interfaces. Good knowledge on the Labware databases. Work on the backlogs, fixing the bugs, and working on the change requests. Work experience on the Labware Migration projects. Very good technical understanding and hands on experience with software development projects. Proficient in usage of processes such as change control, version control, release management, service management and the related tools like JIRA, HPSM, GEAR, source code repositories. Excellent knowledge of GMP in the context of electronic systems. Experience in international manufacturing environment, ideally in the Healthcare and Lifescience industry : Candidate should hold a Bachelors degree in a computer system, engineer or Technical graduation. 6+ years of working experience in Labware LIMS, Web Services (REST & SOAP) Proficient in all technical aspects of Interfaces development (SAP), LIMS Basics, preferably Labware LIMS, Subroutines, Instrument interfaces. Good knowledge on the Labware databases. Work on the backlogs, fixing the bugs, and working on the change requests. Work experience on the Labware Migration projects. Very good technical understanding and hands on experience with software development projects. Proficient in usage of processes such as change control, version control, release management, service management and the related tools like JIRA, HPSM, GEAR, source code repositories. Excellent knowledge of GMP in the context of electronic systems. Experience in international manufacturing environment, ideally in the Healthcare and Lifescience industry Candidate should hold a Bachelors degree in a computer system, engineer or Technical graduation. 6+ years of working experience in Labware LIMS, Web Services (REST & SOAP) Proficient in all technical aspects of Interfaces development (SAP), LIMS Basics, preferably Labware LIMS, Subroutines, Instrument interfaces. Good knowledge on the Labware databases. Work on the backlogs, fixing the bugs, and working on the change requests. Work experience on the Labware Migration projects. Very good technical understanding and hands on experience with software development projects. Proficient in usage of processes such as change control, version control, release management, service management and the related tools like JIRA, HPSM, GEAR, source code repositories. Excellent knowledge of GMP in the context of electronic systems. Experience in international manufacturing environment, ideally in the Healthcare and Lifescience industry
Posted 1 month ago
6.0 - 8.0 years
7 - 11 Lacs
Bengaluru
Work from Office
JOB DESCRIPTION Job Title: Pharma regulatory officer Job Location: Bengaluru Reporting Grade: 6-I Job Grade: 7 About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: To assist pharma regulatory team of Syngene in executing submissions for various licensing activities and follow up with regulators to ensure timely approvals. Role Accountabilities: Preparation and submission of CT-10, CT-12, CT-13, CT-16, Form 12 applications to CDSCO (biological and small molecules), Export NOC, Form 29, GMP, WHO-GMP, license retention, Form 37, COPP, WC and endorsement applications to CDSCO and SLA as applicable. Respond to regulator s queries by collaborating with internal and external stakeholders. Follow-ups for approvals with CDSCO, Zone, SLA and NCB. Filling quarterly returns to NCB and maintain compliance to RCS, 2013. Supporting the team in preparation of IBSC and RCGM application, coordinate and convene IBSC meetings on behalf of member secretary, IBSC. Providing consultation to the internal stakeholders and clients regarding national regulatory requirements as and when required. Maintenance of all submissions and approvals record by maintaining database and trackers. Manufacturing licenses (R&D and commercial), import and export permissions, liaising with State regulators. Providing time to time update to the stakeholders on the licenses and participating in teleconferences/ discussions with stakeholders / clients as required. Prepare new SOPs as and when required, update current SOPs periodically. Keep all operating units updated on recent change in rules and regulations governing product development life cycle. Leadership Capabilities: Maintain a culture of collaboration and team building in the department. Foster behavior for continuous learning and development Clear and precise communication while collaborating with stakeholders. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 6-8 years Demonstrated Capability: Able to make error free submissions and ensure timely approvals. Attention to detail Time management Education: M.Pharma/M.Sc./equivalent Skills and Capabilities 1. Excellent analytical & reasoning skills 2. Good communication (verbal and written) skills 3. Proactiveness and good time management skills 4. Sound working knowledge of national pharma regulatory affairs landscape. Equal Opportunity Employer: .
Posted 1 month ago
3.0 - 6.0 years
8 - 12 Lacs
Bengaluru
Work from Office
About Apotex Inc. Job Summary Execution of analytical method optimization /development, validation/ verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes( SDC) and other procedural updations.Preparation of method validation/verification protocols and reports. Job Responsibilities Execution of Method optimization / development studies. Method validation/ verification of In-house methods, Compendia, SDC, MLCM and Cleaning Analytical methods by adhering to the regulatory procedures. Preparation of Method verification/ Method transfer Protocols and reports. Execution of Method transfer analysis and reporting. Execution of analytical studies related to Regulatory queries/submisiion requirement. Perform all work in accordance with all established regulatory compliance and safety requirements. Responsible for the activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality system. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education MinimumMSc/BPharm or any equivalent degree. Knowledge, Skills and Abilities Command on Microsoft-Office (Word, Excel). Knowledge in Method optimization/development activities. Best in effective completion of work activities to meet the time lines. Able to perform multi parameter analysis on HPLC instrument. Experience: Minimum 3 to 6 years of experience in GMP regulated Pharmaceutical Industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Posted 1 month ago
2.0 - 5.0 years
3 - 7 Lacs
Bengaluru
Work from Office
About Apotex Inc. Job Summary Responsible for Calibration, Thermal Mapping, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Deputy Manager - Engineering and Maintenance at ARPL for day to day engineering activities of allotted Job responsibilities. Execute in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance work orders wrt instruments. Co-ordinate for all engineering department trainings as per established procedures. Execute / supervise with the help of contractor s on daily basis or as and when required for follow up and completion of calibration, thermal mapping, Qualification and other engineering cGMP documentation activities and projects. Execute / supervise the engineering department online documentation all time with respect to Risk Assessment / Calibration / Thermal Mapping / Planner / Logbooks. Update master calibration schedules, Thermal mapping schedules in SAP, update calibration records, calibration reports review and archival. Prepare Performance Qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS department personnel. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory and compliance and safety requirements. Follow up with cross functional team for on time closure of CAPA, CCR, Deviations / investigations with respect to calibration and Thermal mapping. Notification creation, Confirmation, and TECO updation for PM & CM work orders in SAP PM module Execute Master data related activities in SAP. Preparation and review of Risk assesments. All other duties as assigned. Job Requirements Education Bachelors degree in Engineering. Knowledge, Skills and Abilities Should have knowledge in Calibration and Thermal Mappping and its related Documentation. Should have knowledge in QMS documentation. Should have knowledge in utilities systems and equipment s. Should have knowledge in Preventive maintenance process. Works effectively towards achieving the engineering compliance. Should have good interpersonal and communicational skills. Hands on experience in Track wise application, SAP and MS Office etc. Should have knowledge in ISPE, ISO and WHO Guidelines with respect to Calibration and Thermal Mapping process. Should have audit exposure to any of the regulatory audits like USFDA, MHRA, HC and TGA. Strives to drive projects related to engineering. Experience Minimum 8 years experience in Pharmaceutical Industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Posted 1 month ago
11.0 - 15.0 years
15 - 16 Lacs
Bengaluru
Work from Office
Job Summary Responsible for the effective and timely execution of the material planning & production, lab scheduling . Regular review of materials inventory for expiring material, and determine re-tests. Creation of Production and Lab Scheduling, MRP Controllers, Logistics personnel, and Procurement personnel within their area and at other sites of the plant . where synergies and common issues exist to obtain best value for the organization. Job Responsibilities Collaborate with cross functional team (Production ,Lab, Warehouise and Logistics) Identify and drive continuous improvement opportunities to streamline process and improve accuracy and efficiency within operations. Should have knowledge of Supply Chain and Materials Management Systems Ability to forge positive relationships and communicate effectively with all levels of management and with all departments Show initiative by undertaking self-development activities, seeking increased responsibilities, and Well known with SAP/ERP/S4 HANA softwares Overall accountability to ensure and maintain RM readiness to execute monthly manufacturing plans including liaising with procurement Responsible for lab scheduling to get, Prodction schedule execution, FG releases on time and meet supply commmitments. Handling of Change control, Deviation, and CAPA through QMS Trackwise. Advanced understanding of capacity analysis to determine scheduling limitations using RCCP Tool. Maintain open/continuous communication with documentation, production, validation, warehousing, NPL, purchasing, quality assurance, laboratory and packaging staff to support activities on the production floor. Operate in full compliance with good manufacturing practices, standard operating procedures and department work instructions. Managing Inventory levels to minimize production risk while maximizing inventory turns. Identifying and driving adoption of Key Performance Indicators as they apply to Supply Chain success, as well as providing input to KPIs as they apply to Manufacturing success. Management of supplier relationships and development of partnerships to ensure efficient use of resources and effective material and component supply practices Monitoring open Purchase Orders and Stock Status reports and expediting order fulfillment to ensure on time delivery Leading the internal initiative to implement and maintain an effective and accurate physical inventory system, including ERP transaction accuracy, physical inventory events, and cycle counting as appropriate The key objectives of this role are to develop and lead proper execution of planning strategies in addition to overseeing activities of the Supply Chain Planning Team and directing the Planners to reach optimal operational efficiencies. This candidate must possess excellent information analytic skills. Participates in existing and new product planning processes to assure timely acquisition of materials to support product launches. Establishes annual goals and objectives, (including stretch targets) in coordination with company objectives, and Performs other duties as assigned. manages performance to ensure attainment Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion. All other duties as assigned. Job Requirements Education: Minimum Bachelor Degree holder in Science or Pharmacy. Knowledge, Skills and Abilities Possess sound knowledge in Manufacturing scheduling. Should possess excellent communication skills (Verbal and written). Good interpersonal skills. Right attitude and work temperament. MS office (word, excel and Powerpoint presentation) Hands-on experience in Trackwise application, SAP, Content Server etc. Strives to drive projects related to Quality Systems effectively. Experience - Minimum 5 years of experience in GMP Regulated Pharmaceutical industry At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Posted 1 month ago
3.0 - 8.0 years
3 - 6 Lacs
Bengaluru
Work from Office
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for Qualification and validation, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Assistant Manager - Engineering and Maintenance at ARPL for day-to-day engineering activities of allotted Job responsibilities. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Ensure preparation of protocols and completion of Facility Qualification, IOQ, PQ for modified and newly created area as per the organization requirements. Ensure completion of test like Air velocity and Number of air changes, Class of Air- Non-viable Particle count, Airflow Direction/Pattern & HEPA Filter integrity for Air handling unit qualification. Receipt and review of Qualification Reports and Certificates from qualification service provider. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Execute / supervise the engineering department online documentation all time with respect to Equipment Qualification / Re-Qualification / Risk Assessment / Training / Re-Evaluation / Planner / Logbooks. Preparation, updating, Review and archival of Qualification protocols, filter replacement schedules, QSR documents. Prepare Performance Re-qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe workplace at ARPL all time in coordination to EHS personnel. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Ensuring and maintaining engineering inventory management /upkeep of minimum stock availability for engineering spares. Execute / supervise with the help of contractors on daily basis for follow up and completion of Qualification and other engineering cGMP documentation activities and projects. Coordinating and Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory compliance and safety requirements. Notification creation, confirmation and TECO of Preventive Maintenance & Corrective Maintenance work orders in SAP Module. Demonstrate Behaviours that exhibit our organizational values values: Collaboration, Courage, Perseverance and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance program, Global Quality policies and procedures, Safety and Environment policies and HR policies. All other duties as assigned. Job Requirements Education Minimum Diploma Engineering/Bachelors degree in Engineering Knowledge, Skills and Abilities Having Knowledge in Calibration, Thermal Mapping, Qualification and its related Documentation. Having knowledge in QMS documentation. Having knowledge in utilities systems and equipment s. Having knowledge in Preventive maintenance process. Having good interpersonal and communicational skills. Having knowledge of ISPE, ISO and WHO Guidelines for pharmaceutical equipment and area Qualification. Shall have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA. Etc., Experience Minimum 3 years of experience for bachelor s degree or 5 years of experience for diploma in engineering in pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Posted 1 month ago
2.0 - 3.0 years
3 Lacs
Mehsana
Work from Office
Position Title: Operator- Process (Fryer, Freezer) Position Type: Regular - Full-Time Position Location: Mehsana Grade: Grade 01 Requisition ID: 36323 Global Job Descriptions Job Details: Function/Department : Production Global Job Grade Job Title: Process Operator Region*: APEMA Global Grading System Job Code: Global Job Grade : Evaluation Date : March 14, 2012 Global Pay Band : 3 Global Benchmark Job : Yes This is a generic job title to be used for Job Administration. Job titles used by individuals may vary by country but the position should be aligned to the generic job title for Job Administration purposes. *e.g. Global/APMEA/NA/CE/etc. Instructions for Position Summary: Brief description of the primary purpose of the position, with emphasis on the outcomes or results expected (rather than what is specifically done). This should briefly describe why the job exists. Consider how you would describe the job to someone you ve just met. Position Summary: To ensure that all equipment in the process section (Blancher, SAPP / Dextrose System, Dryer, Fryer and Freezing) is operating to it s full potential in order to supply the production line with the required quantity and quality of specified processed cut potatoes. Recording / monitoring of both quality / processed efficiencies while ensuring area and staff are hygienically clean Instructions for Responsibilities and Accountabilities: List the major responsibilities and accountabilities of the position in order of importance with most important being first etc. Each item should describe what the person in this position have to accomplish at McCain. (i.e. what the job produces) as well as the key activities that lead to the outcomes: Responsibilities and Accountabilities: OPERATING OF PROCESS SECTION o Blancher area: ensure that equipment is set to the standard required for the specific product process. Monitor water levels, quality, and usage. o Ensure temperature, retention times, alarms are all set within the RS view system. Monitor / record yield loss, colour, texture and any breakage. o SAAP / Dextrose System: ensure that equipment is set to the standard required for the specific product process. Monitor Dextrose / SAPP percentage, water quality and ingredient usage. o Ensure temperature and alarms are all set within the RS view system. Monitor / record colour and any breakage. o Dryer Area: ensure that equipment is set to the standard required for the specific product process. o Ensure temperature, retention times, alarms are all set within the RS view system. . Monitor / record yield loss and any breakage. o Fryer Area: ensure that equipment is set to the standard required for the specific product process. o Ensure temperature, retention times, alarms are all set within the RS view system. Monitor / record yield loss, oil usage / quality and any product breakage. o Freezing Area: ensure that equipment is set to the standard required for the specific product process. Global Job Descriptions o Ensure temperature, retention times, alarms are all set within the RS view system. Monitor / record temperature and any product breakage. o Ensure all process waste is dumped, weighed and recorded on the operational sheet. o Maintain all hourly data in online tools like TSU live, SPC. NEATNESS OF WORK PLACE o Ensure that the walls, walkways and floors are clean at all times during production. o Ensure that the equipment in this section is clean at all times. o When there is no processing activity in the process section, to continue with cleaning ensuring a neat and effective production shift. o All staff working in this area has clean uniforms and are presented tidy. o All waste is disposed of in the correct containers and is removed / emptied into the appropriate waste areas. MAINTENANCE & GENERAL DUTIES o Assists with engineers during break downs. o Communicates to Supervisor in cases of change over in process and ensures product appearance is satisfactory with Quality Control at finished product. o During break times the process operator will be required to cover other operators. o Carryout daily checks on the condition of the process area section. o Report any defects in equipment performance to the Supervisor. o Carryout simple adjustments to keep equipment running at optimal efficiency. o Replace consumable parts as required and any other duties deemed reasonable. SAFETY o Ensure all equipment / motor covers are fitted securely. o No loose wires or electrical panels are open to the environment (Only engineers have access to electrical panels). o All floors are kept dry to minimize slips. o All staff in the cutting area is wearing Personnel Protective Equipment (PPE). Instructions for Requirements: Record the ideal qualifications for someone to take on this job (note: current incumbents may have different backgrounds). If you were looking to hire someone for this job, what background and qualifications would be required and/or desired This should briefly describe what a person needs to be successful in this position. Requirements: Academic: Must have: ITI OR should posses min. 2years experience of Food Industry Nice to have: Professional/Technical Accreditations: Must have: Nice to have: Global Job Descriptions Related Work Experience (Internal to the organization or external): Minimum 2-3 experience Process and packing area Instructions for Working Relationships and Key Contacts: Record the typical contacts both internal and external that someone in this position would have during a normal working day/week. Please do not record names - identify contacts by broad category (e.g. clients ) if external to the organization, or by title ( Manager, Finance ) for contacts within the organization. Describe the purpose of the communication in a few words (i.e. provide information , confirm transaction ). Working Relationships and Key Contacts: Contact Purpose Internal: 1 Production Manager / Production Executive / Area leader Production / Shift leader Production For Day to Day Reporting 2 Maintenance Area leader / Fitter For maintenance related issue 3 QA Executive / QA Area leader / QA Chemist For quality / GMP related matter External 1 2 3 Authorities: Budget: Managing People (# of direct reports): Other: Competencies: Critical TECHNICAL (Function-Specific) Competencies: o Have knowledge of OEE. o Proper documentation and Knowledge of GMP regulations o Speck, read and write English. o Should able to understand process, Should posses knowledge of Efficiency and Yield/ recovery Critical CORE (General Behavioral and Business) Competencies: o He should be good communicator, coordinator. o He should have sound analytical skill. o Team player Global Job Descriptions Instructions for Additional Information: Record the description of other information relevant to the position, such as travel requirements, details about the team. This should briefly describe what else we need to know about this position in order to recruit the right person. Additional Information: Organization Relationships: Immediate Manager/Supervisor (title) Area Leader Peer Job (title) Job Title Peer Job (title) Control Room Operator Process operator Forklift operators McCain Foods is an equal opportunity employer. As a global family-owned company, we strive to be the employer of choice in the diverse communities around the world in which we live and work. We recognize that inclusion drives our creativity, resilience, and success and makes our business stronger. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, veteran status, disability, or any other protected characteristic under applicable law. McCain is an accessible employer. If you require an accommodation throughout the recruitment process (including alternate formats of materials or accessible meeting rooms), please let us know and we will work with you to find appropriate solutions. Your privacy is important to us. By submitting personal data or information to us, you agree this will be handled in accordance with McCain s Global Privacy Policy and Global Employee Privacy Policy , as applicable. You can understand how your personal information is being handled here . Job Family: Manufacturing Division: India Department: Production Line 4 Team 1 Location(s): IN - India : Gujarat : Mehsana Company: McCain Foods(India) P Ltd "
Posted 1 month ago
3.0 - 5.0 years
4 - 8 Lacs
Mehsana
Work from Office
Position Title: Packing AL Position Type: Regular - Full-Time Position Location: Mehsana Grade: Grade 02 Requisition ID: 36782 Job Details: Function/Department : Production Global Job Grade Job Title: Area Leader Packaging Region*: APEMA Global Grading System Job Code: Global Job Grade : Evaluation Date : Global Pay Band : 2 Global Benchmark Job : Yes This is a generic job title to be used for Job Administration. Job titles used by individuals may vary by country but the position should be aligned to the generic job title for Job Administration purposes. *e.g. Global/APMEA/NA/CE/etc. Instructions for Position Summary : Brief description of the primary purpose of the position, with emphasis on the outcomes or results expected (rather than what is specifically done). This should briefly describe why the job exists. Consider how you would describe the job to someone you ve just met. Position Summary : To supervise and co-ordinate the packing operation, ensuring the product is packed within the product specifications. To ensure, optimize productivity / yield, utilizing the staff / equipment in a safe, effective and hygienic manner. Instructions for Responsibilities and Accountabilities : List the major responsibilities and accountabilities of the position in order of importance with most important being first etc. Each item should describe what the person in this position have to accomplish at McCain. (i.e. what the job produces) as well as the key activities that lead to the outcomes: Responsibilities and Accountabilities : PACKING EFFIECIENCIES & RECOVERY Supervise that efficiency standards are maintained and subsequent planned production volumes are packed. Control the packing parameters in order to ensure the yield ratio between packing materials issued and finished products are packed within budget. Record all waste generated within the packing area and investigate whenever excessive waste is found. Ensure all operation work procedures adhered to for optimal packing efficiencies / yield. Educate and train employees to ensure they are fully aware of all standards required within the packing area. Organize casual labour and maintain the effectiveness of personal in order to achieve the optimum labour utilization to complete packing schedule. Communicate packing out-put, downtime or quality issues to the control room on an hourly basis. Focus on manual packing for NCP, variety pack and make sure all manual packing should finish within timeline. QUALITY Ensure packing line is set up to comply with the final product specifications. Communicate with the QC concerning corrective action reports, related to quality problems that occur within the packing area. Maintain all quality checks within specified parameters, ensuring traceability. All non-conformance product is identified / recorded and Production Executive, control room operator have been notified. Customer complaints and restricted products are within the specified targets. Mapping and execution of NPD trials in plant, relevant study cases need to be documented and kept secured NEATNESS OF WORK PLACE Ensure that the walls, walkways and floors are clean at all times during production. Ensure that the equipment in this section is clean at all times. When there is no packing activity in the packing section, continue with cleaning ensuring a neat and effective production shift. The packing staff must turn out daily in clean uniforms and are presented tidy. All waste is disposed of in the correct containers and is removed / emptied into the appropriate waste areas. MAINTENANCE & GENERAL DUTIES Communicates with Production Executive, control room operator to ensure no break downs. Communicates with shop floor staff at all times reference performance out-put, recognizing staffs achievements. Keeps staff up to date with any changes to company procedures or policy. Assists with engineers during break downs. During break times staff will be required to cover other positions. Carryout daily checks on the condition of the packing area section. Report any defects in equipment performance to the Production Executive, control room operator and engineers. Fills out job card to fix defective equipment. Carryout simple adjustments to keep equipment running at optimal efficiency. Replace consumable parts as required and any other duties deemed reasonable. To perform any other reasonable work related tasks as instructed by Production Executive SAFETY Ensure all equipment / motor covers are fitted securely. No loose wires or electrical panels are open to the environment (Only engineers have access to electrical panels). All floors are kept dry to minimize slips. All staff in the packing area is wearing Personnel Protective Equipment (PPE). Train an update all staff in relation to all safety issues within the packing area. Anticipates and identifies safety related problems, takes corrective action to resolve the safety issue. Carries out monthly safety inspection of the packing area. Instructions for Requirements : Record the ideal qualifications for someone to take on this job (note: current incumbents may have different backgrounds). If you were looking to hire someone for this job, what background and qualifications would be required and/or desired This should briefly describe what a person needs to be successful in this position. Requirements: Academic: Must have: ITI OR should posses min. 3 years experience of Food Industry Nice to have: Professional/Technical Accreditations: Must have: Nice to have: Related Work Experience (Internal to the organization or external): Minimum 3-5 years experience in packing area Instructions for Working Relationships and Key Contacts : Record the typical contacts both internal and external that someone in this position would have during a normal working day/week. Please do not record names - identify contacts by broad category (e.g. clients ) if external to the organization, or by title ( Manager, Finance ) for contacts within the organization. Describe the purpose of the communication in a few words (i.e. provide information , confirm transaction ). Working Relationships and Key Contacts: Contact Purpose Internal: 1 Production Manager / Production Executive / Area leader Production For Day to Day Reporting 2 Maintenance Area leader / Fitter For maintenance related issue 3 QA Executive / QA Area leader / QA Chemist For quality / GMP related matter External 1 2 3 Authorities: Budget: Managing People (# of direct reports): Other: Competencies: Critical TECHNICAL (Function-Specific) Competencies: Should report incidents, material loss by improper handling or behavior to Production Manager/ Production executive. Have knowledge of OEE and performing 5S, Kaizens. Candidates should knowledge of food processing packing area. Should able to understand process, identify gaps by root cause analysis and correct in timely manner. Should posses knowledge of Efficiency and Yield/ recovery Should able to do shift planning, any changes should be reported and communicated to superiors Critical CORE (General Behavioral and Business) Competencies: Have leadership skill to handle more than 40workmens. He should be good communicator, coordinator.. He should have sound analytical and decision making skill Should be highly self motivated and motivate his team driving results. Instructions for Additional Information : Record the description of other information relevant to the position, such as travel requirements, details about the team. This should briefly describe what else we need to know about this position in order to recruit the right person. Additional Information: Organization Relationships: Immediate Manager/Supervisor (title) Production Shift Executive Peer Job (title) Job Title Peer Job (title) Area Leader Production Area leader Packaging Shift leader Title(s) of those reporting directly to the job Process operator Asst. area Leader Packing Operator Asst. Area Leader McCain Foods is an equal opportunity employer. As a global family-owned company, we strive to be the employer of choice in the diverse communities around the world in which we live and work. We recognize that inclusion drives our creativity, resilience, and success and makes our business stronger. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, veteran status, disability, or any other protected characteristic under applicable law. McCain is an accessible employer. If you require an accommodation throughout the recruitment process (including alternate formats of materials or accessible meeting rooms), please let us know and we will work with you to find appropriate solutions. Your privacy is important to us. By submitting personal data or information to us, you agree this will be handled in accordance with McCain s Global Privacy Policy and Global Employee Privacy Policy , as applicable. You can understand how your personal information is being handled here . Job Family: Manufacturing Division: India Department: Production Line 4 Team 3 Location(s): IN - India : Gujarat : Mehsana Company: McCain Foods(India) P Ltd "
Posted 1 month ago
2.0 - 3.0 years
3 Lacs
Mehsana
Work from Office
Position Title: Operator- Process Mixture & Preparation Position Type: Regular - Full-Time Position Location: Mehsana Requisition ID: 36783 Global Job Descriptions Job Details: Function/Department : Production Global Job Grade Job Title: Process Operator Region*: APEMA Global Grading System Job Code: Global Job Grade : Evaluation Date : March 14, 2012 Global Pay Band : 3 Global Benchmark Job : Yes This is a generic job title to be used for Job Administration. Job titles used by individuals may vary by country but the position should be aligned to the generic job title for Job Administration purposes. *e.g. Global/APMEA/NA/CE/etc. Instructions for Position Summary: Brief description of the primary purpose of the position, with emphasis on the outcomes or results expected (rather than what is specifically done). This should briefly describe why the job exists. Consider how you would describe the job to someone you ve just met. Position Summary: To ensure that all equipment in the process section (Blancher, SAPP / Dextrose System, Dryer, Fryer and Freezing) is operating to it s full potential in order to supply the production line with the required quantity and quality of specified processed cut potatoes. Recording / monitoring of both quality / processed efficiencies while ensuring area and staff are hygienically clean Instructions for Responsibilities and Accountabilities: List the major responsibilities and accountabilities of the position in order of importance with most important being first etc. Each item should describe what the person in this position have to accomplish at McCain. (i.e. what the job produces) as well as the key activities that lead to the outcomes: Responsibilities and Accountabilities: OPERATING OF PROCESS SECTION o Blancher area: ensure that equipment is set to the standard required for the specific product process. Monitor water levels, quality, and usage. o Ensure temperature, retention times, alarms are all set within the RS view system. Monitor / record yield loss, colour, texture and any breakage. o SAAP / Dextrose System: ensure that equipment is set to the standard required for the specific product process. Monitor Dextrose / SAPP percentage, water quality and ingredient usage. o Ensure temperature and alarms are all set within the RS view system. Monitor / record colour and any breakage. o Dryer Area: ensure that equipment is set to the standard required for the specific product process. o Ensure temperature, retention times, alarms are all set within the RS view system. . Monitor / record yield loss and any breakage. o Fryer Area: ensure that equipment is set to the standard required for the specific product process. o Ensure temperature, retention times, alarms are all set within the RS view system. Monitor / record yield loss, oil usage / quality and any product breakage. o Freezing Area: ensure that equipment is set to the standard required for the specific product process. Global Job Descriptions o Ensure temperature, retention times, alarms are all set within the RS view system. Monitor / record temperature and any product breakage. o Ensure all process waste is dumped, weighed and recorded on the operational sheet. o Maintain all hourly data in online tools like TSU live, SPC. NEATNESS OF WORK PLACE o Ensure that the walls, walkways and floors are clean at all times during production. o Ensure that the equipment in this section is clean at all times. o When there is no processing activity in the process section, to continue with cleaning ensuring a neat and effective production shift. o All staff working in this area has clean uniforms and are presented tidy. o All waste is disposed of in the correct containers and is removed / emptied into the appropriate waste areas. MAINTENANCE & GENERAL DUTIES o Assists with engineers during break downs. o Communicates to Supervisor in cases of change over in process and ensures product appearance is satisfactory with Quality Control at finished product. o During break times the process operator will be required to cover other operators. o Carryout daily checks on the condition of the process area section. o Report any defects in equipment performance to the Supervisor. o Carryout simple adjustments to keep equipment running at optimal efficiency. o Replace consumable parts as required and any other duties deemed reasonable. SAFETY o Ensure all equipment / motor covers are fitted securely. o No loose wires or electrical panels are open to the environment (Only engineers have access to electrical panels). o All floors are kept dry to minimize slips. o All staff in the cutting area is wearing Personnel Protective Equipment (PPE). Instructions for Requirements: Record the ideal qualifications for someone to take on this job (note: current incumbents may have different backgrounds). If you were looking to hire someone for this job, what background and qualifications would be required and/or desired This should briefly describe what a person needs to be successful in this position. Requirements: Academic: Must have: ITI OR should posses min. 2years experience of Food Industry Nice to have: Professional/Technical Accreditations: Must have: Nice to have: Global Job Descriptions Related Work Experience (Internal to the organization or external): Minimum 2-3 experience Process and packing area Instructions for Working Relationships and Key Contacts: Record the typical contacts both internal and external that someone in this position would have during a normal working day/week. Please do not record names - identify contacts by broad category (e.g. clients ) if external to the organization, or by title ( Manager, Finance ) for contacts within the organization. Describe the purpose of the communication in a few words (i.e. provide information , confirm transaction ). Working Relationships and Key Contacts: Contact Purpose Internal: 1 Production Manager / Production Executive / Area leader Production / Shift leader Production For Day to Day Reporting 2 Maintenance Area leader / Fitter For maintenance related issue 3 QA Executive / QA Area leader / QA Chemist For quality / GMP related matter External 1 2 3 Authorities: Budget: Managing People (# of direct reports): Other: Competencies: Critical TECHNICAL (Function-Specific) Competencies: o Have knowledge of OEE. o Proper documentation and Knowledge of GMP regulations o Speck, read and write English. o Should able to understand process, Should posses knowledge of Efficiency and Yield/ recovery Critical CORE (General Behavioral and Business) Competencies: o He should be good communicator, coordinator. o He should have sound analytical skill. o Team player Global Job Descriptions Instructions for Additional Information: Record the description of other information relevant to the position, such as travel requirements, details about the team. This should briefly describe what else we need to know about this position in order to recruit the right person. Additional Information: Organization Relationships: Immediate Manager/Supervisor (title) Area Leader Peer Job (title) Job Title Peer Job (title) Control Room Operator Process operator Forklift operators McCain Foods is an equal opportunity employer. As a global family-owned company, we strive to be the employer of choice in the diverse communities around the world in which we live and work. We recognize that inclusion drives our creativity, resilience, and success and makes our business stronger. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, veteran status, disability, or any other protected characteristic under applicable law. McCain is an accessible employer. If you require an accommodation throughout the recruitment process (including alternate formats of materials or accessible meeting rooms), please let us know and we will work with you to find appropriate solutions. Your privacy is important to us. By submitting personal data or information to us, you agree this will be handled in accordance with McCain s Global Privacy Policy and Global Employee Privacy Policy , as applicable. You can understand how your personal information is being handled here . Job Family: Manufacturing Division: India Department: Production Line 4 Team 1 Location(s): IN - India : Gujarat : Mehsana Company: McCain Foods(India) P Ltd "
Posted 1 month ago
0.0 - 7.0 years
3 Lacs
Mehsana
Work from Office
Position Title: Operator- Cleaning and Sanitation Position Type: Regular - Full-Time Position Location: Mehsana Grade: Grade 01 Requisition ID: 36784 McCain Foods India Private Limited - MEHSANA JOB DESCRIPTION & COMPETENCY HR / JD / PRO / Asst. Exe. Revised on : Rev No.: Prepared On: 1/12/2009 POSITION : Bagger Operator Packing REPORTING TO : Packing Area Leader QUALIFICATION : ITI and should posses min. 1years experience of Food Industry EXPERIENCE 1 years AGE Minimum 21 years COMPETENCIES A) Functional Competencies: Candidates should knowledge of food processing packing area. Should able to understand process, Should posses knowledge of Efficiency and Yield/ recovery Have knowledge of OEE and performing 5S, Kaizens. Proper documentation and Knowledge of GMP regulations A) Behavioral Competencies He should be good communicator, coordinator. He should have sound analytical. Decision making skill JOB DESCRIPTION JOB OBJECTIVE To operate and co-ordinate the packing operation, ensuring the product is packed within the product specifications. To ensure, optimize productivity / yield, utilizing the staff / equipment in a safe, effective and hygienic manner. Key Performance Areas 1. PACKING EFFIECIENCIES & RECOVERY 1.1 Oversee that efficiency standards are maintained and subsequent planned production volumes are packed. 1.2 Control the packing parameters in order to ensure the yield ratio between packing materials issued and finished products are packed within budget. 1.3 Record all waste generated within the packing area and investigate whenever excessive waste is found. 1.4 Educate and train employees to ensure they are fully aware of all standards required within the packing area. 1.5 Communicate packing out-put, downtime or quality issues to the control room on an hourly basis. McCain Foods India Private Limited - MEHSANA JOB DESCRIPTION & COMPETENCY HR / JD / PRO / Asst. Exe. Revised on : Rev No.: Prepared On: 1/12/2009 2. QUALITY 2.1 Ensure packing line is set up to comply with the final product specifications. 2.2 Liaise with the QC concerning corrective action reports, related to quality problems that occur within the packing area. 2.3 Maintain all quality checks within specified parameters, ensuring traceability. 2.4 All non-conformance product is identified / recorded and Production Executive, control room operator have been notified. 2.5 Customer complaints and restricted products are within the specified targets. 3. NEATNESS OF WORK PLACE 3.1 Ensure that the walls, walkways and floors are clean at all times during production. 3.2 Ensure that the equipment in this section is clean at all times. 3.3 When there is no packing activity in the packing section, continue with cleaning ensuring a neat and effective production shift. 3.4 The packing staff must turn out daily in clean uniforms and are presented tidy. 3.5 All waste is disposed of in the correct containers and is removed / emptied into the appropriate waste areas. 4. MAINTENANCE & GENERAL DUTIES 4.1 Communicates with Production Executive, control room operator to ensure no break downs. 4.2 Communicates with shop floor staff at all times reference performance out-put, recognizing staffs achievements. Keeps staff up to date with any changes to company procedures or policy. 4.3 Assists with engineers during break downs. 4.4 During break times staff will be required to cover other positions. 4.5 Carryout daily checks on the condition of the packing area section. 4.6 Report any defects in equipment performance to the Production Executive, control room operator and engineers. Fills out job card to fix defective equipment. 4.7 Carryout simple adjustments to keep equipment running at optimal efficiency. 4.8 Replace consumable parts as required and any other duties deemed reasonable. 4.9 To perform any other reasonable work related tasks as instructed by Production Executive. 5. 2 SAFETY 5.1 Ensure all equipment / motor covers are fitted securely. 5.2 No loose wires or electrical panels are open to the environment (Only engineers have access to electrical panels). 5.3 All floors are kept dry to minimize slips. 5.4 All staff in the packing area is wearing Personnel Protective Equipment (PPE). 5.5 Train an update all staff in relation to all safety issues within the packing area. 5.6 Anticipates and identifies safety related problems, takes corrective action to resolve the safety McCain Foods India Private Limited - MEHSANA JOB DESCRIPTION & COMPETENCY HR / JD / PRO / Asst. Exe. Revised on : Rev No.: Prepared On: 1/12/2009 issue. McCain Foods is an equal opportunity employer. As a global family-owned company, we strive to be the employer of choice in the diverse communities around the world in which we live and work. We recognize that inclusion drives our creativity, resilience, and success and makes our business stronger. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, veteran status, disability, or any other protected characteristic under applicable law. McCain is an accessible employer. If you require an accommodation throughout the recruitment process (including alternate formats of materials or accessible meeting rooms), please let us know and we will work with you to find appropriate solutions. Your privacy is important to us. By submitting personal data or information to us, you agree this will be handled in accordance with McCain s Global Privacy Policy and Global Employee Privacy Policy , as applicable. You can understand how your personal information is being handled here . Job Family: Manufacturing Division: India Department: India Plant Hygeine Generic Location(s): IN - India : Gujarat : Mehsana || IN - India : Gujarat : Ahmedabad || IN - India : Gujarat : Bhavnagar || IN - India : Gujarat : Rajkot || IN - India : Gujarat : Surat || IN - India : Gujarat : Vadodara Company: McCain Foods(India) P Ltd "
Posted 1 month ago
2.0 - 5.0 years
9 - 13 Lacs
Bengaluru
Work from Office
What if the work you did every day could impact the lives of people you knowOr all of humanity At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Responsibilities: Ensures efficient processing of custom and off the shelf direct materials purchase requisitions driven by a planning process in a manufacturing environment. Owns the assigned suppliers and parts for the timely delivery of materials to the manufacturing site to satisfy requirements for manufacturing and spare parts. Maintains effective collaboration with suppliers to ensure no disruption to Illumina manufacturing and escalates internally and externally for support as needed. Performs management of Supplier part lead times, safety stock, expedites, Supplier Change Notifications (SCNs) and supplier collaboration of delivery reschedules. Collaborates with Planning, Quality, Engineering, Manufacturing teams and Suppliers on material quality issues. May facilitate virtual meetings, publish notes/actions. Collaborates with Sourcing, used SAP material settings and executes purchase orders to optimize pricing tiers, minimum order quantities, supplier capacity plans. Coordinates with supplier, Quality and Warehousing on RMA return to vendor actions including repair and refurbishment. Works with a PLM (Product Lifecycle Management) system with access to specifications, part diagrams, work instructions, etc.. Works with Reliance / ETQ quality management system, actions assignments, documents changes. Responsible for procurement business system data input and integrity, is champion for Suppliers using our Ariba B2B solutions, portals and collaboration tools. Ensures accuracy of confirmed delivery dates for materials on our SAP system and negotiates with suppliers as necessary to expedite or push out deliveries. Drives on time delivery, inventory turnover, requisition conversion and other key performance indicators (KPIs) for the assigned suppliers. Secures part certifications as appropriate from suppliers for successful global distribution of spare parts. May recommend cost saving proposals to suppliers in collaboration with Sourcing teams. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements: Experience in Global suppliers and stakeholder management SAP ECC MM module and MRP knowledge Ariba SCC knowledge preferred Thorough knowledge of direct procurement, vendor relations, and inventory management Familiar with GMP s, product specifications incoming inspection procedures Effective verbal and written communication, analytical and interpersonal skills Strong problem solving, organizational skills, detail oriented. Strong influencing and negotiating skills Strong Knowledge of Microsoft Excel and Outlook required Willingness to work in shift to support US Region (No night shift required) Experience/Education: Typically requires a minimum of 3-5 years of related experience with a Bachelor s degree; or 2 years and a Master s degree; or a PhD without experience; or equivalent work experience We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. . To learn more, visit: https: / / www.dol.gov / ofccp / regs / compliance / posters / pdf / eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
Posted 1 month ago
8.0 - 20.0 years
9 - 10 Lacs
Gangtok
Work from Office
Managing and leading a team of executives to achieve sales goals. Developing and implementing strategies to drive business growth. Building and maintaining strong relationships with clients and partners. Analyzing market trends and competitors to make informed decisions. Monitoring sales performance and providing regular reports to senior management. Training and mentoring new team members to ensure their success. Collaborating with other departments to streamline processes and improve efficiency. Representing the company at industry events and conferences. Bachelor s degree in Business Administration or related field. Proven experience in sales and achieving targets. Strong leadership and communication skills. - Ability to think critically and make strategic decisions.
Posted 1 month ago
1.0 - 4.0 years
7 - 11 Lacs
Pune
Work from Office
Aamikza Biotechnology Pvt Ltd is looking for RnD scientist to join our dynamic team and embark on a rewarding career journey Conduct research and develop innovative products or methods Design experiments and analyze technical data Collaborate with cross-functional teams and regulatory bodies Prepare reports and support commercialization
Posted 1 month ago
5.0 - 10.0 years
7 - 12 Lacs
Baddi
Work from Office
Job Purpose: Responsible for all manufacturing activity and target achieving within best quality practices as per GMP Guidelines for production without production hampering. Dimension of Profile: Senior Executive (Manufacturing) analyst has to interact with quality and production department at the site related to any non-compliance in manufacturing. Job Responsibilities: Achieving of the manufacturing target as per production plan. Follow the manufacturing process as per FDA norms & ensure that RM wastages are within control limits. Ensuring minimum loss of product in Manufacturing Process. Improvement of the manufacturing process and production development related to quality. Retain focus on Good House Keeping and Critical Control Point. Focus on creating safe work environment. Conduct training activities from time to time for workers and under staff. Doing production entry in SAP/System. Manufacturing equipment sanitization record and documentation. Well-versed with HACCP, GMP must. Batch monitoring (Store and Quality) (FIFO system). 5 S Training. R&D training Qualifications: Graduate/Post graduation in Chemistry /Microbiology/Biochemistry Experience: Minimum experience of 5-10 years in areas of Bulk Manufacturing. Competencies: Technical: Good knowledge of Bulk Manufacturing concepts. Well-versed with manufacturing operations including working knowledge of relevant equipment. Must have good analytical skills. Able to perform manufacturing independently. Understanding of manufacturing processes. Able to identify process related losses. Behavioral: Able to work and lead a team. Good communication. Should maintain safe working environment in manufacturing area. Job Category: Manufacturing
Posted 1 month ago
0.0 - 6.0 years
3 Lacs
Bengaluru
Work from Office
To follow-up the instructions of Assistant Manager/Dy. Manager- Production and carry out shift production activities as per the plan. Maintains the Logbook as per shift activities. Ensures all the raw materials are available on time for the batches planned and all the required batch sheets are made available. Shall be responsible for making entries in all batch records and other Production related documents and ensure that the recordings are done as and when the operations are completed. Coordinates with Engineering department for the completion of maintenance jobs on time and coordinates with QC on in-process and finished product analysis. Shall follow the GMP and Safety norms in the plant Shall follow the relevant Standard Operating Procedure at various stage of operation. Attending EHS training Program. Shall co-ordinate Production Assistant in maintaining stipulated parameters (like temperature, pH, pressure etc.) during the batch processing. Shall record any abnormality or deviations observed during the processing. Shall maintain Good House Keeping in plant and cleanliness of the equipment. Preparing the instructions (BPCR, BCLR, SOP Check lists etc.) for production of intermediates or APIs according to written procedures. Producing APIs new and, when appropriate, intermediates according to pre-approved instructions. To ensure that production facilities are clean and when appropriate disinfected. To ensure that the necessary calibrations are performed and records kept. To ensure that the premises and equipment are maintained and records kept. To verify the environmental conditions of the controlled area. To have performance control over the contract workmen. To verify the contract worker s health, hygiene conditions for working in controlled areas. To allocate the task to the casuals and have performance control. Responsible to handle tasks other than above assigned by reporting persons time to time.
Posted 1 month ago
9.0 - 16.0 years
9 - 10 Lacs
Bharuch
Work from Office
Shall report to Production Manager for all production and administration related activities. Shall plan and execute the production to achieve the targets set by organization. Shall prepare the monthly and daily shift production plan. Timely review of team member s performance and guiding them to improve on key areas. Shall monitor and plan for internal and external training programs for team members. Monitoring and ensuring the products are processed within desired consumption coefficient limits. Monitoring and controlling of consumption and utilization of consumable, RM and PM. Ensure and manage sufficient and suitably skilled/ trained manpower is available for the production. Ensure the Compliance of GMP and continuous improvement in Quality of product and process. Monitoring and controlling the near misses and incidents, if happened during product processing or material handling. Identifying the areas of improvement in man, machine and material safety. Timely review of internal/ external audit reports and complying with appropriate corrective and preventive actions. Manage the implementation of Hikal policies and maintain the discipline standards with the organization as desired / acceptable by the stakeholders. Train and guide the production team for continuous improvement in quality standards. Shall ensure effective implementation and maintenance of QMS, EMS, OHSAS and Inventory management system. Ensure the quality systems such as change controls, deviations and compliant handling are in place and are effectively implemented. Actively participate in team meetings within function and cross functions with due adherence to the timelines fixed for the discussion. Preparation of Monthly MIS, purchase requisition creation and shift schedule management. Conduct the technical and practical training sessions for the development of team. Assistant Manager - Production supports to carry out all the job activities described under his job profile. In absence of Assistant Manager Production, Production Head shall depute appropriate substitute for of the above responsibilities. Assistant Manager - Production reports to Production Head .
Posted 1 month ago
0.0 - 2.0 years
2 - 4 Lacs
Gangtok
Work from Office
Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system
Posted 1 month ago
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