161 Deviation Jobs - Page 3

Witnessing of manufacturing process (mixing, granulation, blending, compression, coating, capsule filling) & packing (primary/secondary packaging) for solid oral products to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. Oversight of line clearance, equipment and area cleanliness, material verification, and adherence to SOPs. Ensure compliance with data integrity (ALCOA++) standards in all documentation and records related to production and QA oversight. Review of batch documentation to ensure product quality and regulatory compliance. Review of unplanned deviations and CAPA. Review of environmental monitoring data Collaborate with site operations and quality functions to report and ensure resolution of non-conformances or compliance gaps.

Long Description Role- Shift Officer - MDI Manufacturing To Supervise compliance to all CGMP or any other regulatory requirements, including EH&S requirements. Complete self-training and monitor training of team members on relevant SOP. Report any quality concerns or suggestion for improvements SOPs. Execute and supervise all tasks and activities as per the applicable SOPs. Supervision of operations, cleaning and maintenance of MDI process equipment's / area in MDI Production area of unit-3. Planning, execution, monitoring supervision of all unit operation for batch processing and Manufacturing. Co-ordination with cross-functional teams for smooth execution of production plan at shop floor. To ensure documentation of required process parameter as per SOPs. Training and development of subordinates to ensure functioning at shop floor as per cGMP requirements. To ensure status labelling of equipment, machines, area and instruments comply with the requirements. In-process checks during stage wise process as per Batch Manufacturing Record as per Standard Operating Procedure. Gap analysis of defined procedures in BMR / SOP / Protocol and initiation of corrective action. Handling of Quality Management Documents like change control, deviation, CAPA and other related documents. To ensure required inventory of approved consumables in Warehouse. To report of incident, non-conformity immediately to the manager. Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management Education Work Experience

Long Description Annual maintenance contract preparation and preventive maintenance of QC instrument as per approved procedure. Breakdown handling of QC instrument as per approved procedure. Upkeep the records for preventive maintenance and breakdown in SAP. Qualification of New instruments with complete documentation. To participate in failure investigations related to instrument malfunctions. To impart training to the analysts for instrument maintenance and troubleshooting. Co-ordination with service engineer for service/ breakdown related activities To maintain good laboratory practices and discipline in respective work area. Actively taking part in cGMP, training and SOP training as and when required. Supporting for calibration and validation activity of Thermolab Make instruments. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Instrumentation Work Experience 5 to 7 years

Key Responsibilities Process Improvement & Automation Identify repetitive and manual processes ripe for automation across reporting, documentation, and administrative workflows Lead initiatives to streamline operational tasks and improve capacity management Collaborate with cross-functional teams to implement scalable efficiency solutions Reporting & Analytics Own monthly reporting cycles, including dashboards, benchmarking, and methodology-based tracking Proactively refine reporting methods for better transparency and time savings Document & Site Management Maintain and manage SharePoint and Sphere sites, including user permissions, file structures, and content consistency Support migration planning and execution from legacy platforms (Box) to MyDocs (DocShare) Policy Alignment Cycles (PAC) Coordinate PAC verification and documentation efforts twice annually, ensuring change-tracking and comment logging are consistent Business Impact Assessment (BIA) Support Verify and update application lists and organizational structures by location Ensure data integrity and audit-readiness of structured documentation Required Skills & Qualifications Strong eye for identifying automation opportunities and driving operational efficiency Highly organized, detail-oriented, and independently driven Familiarity with platforms like SharePoint, DocShare, Sphere, and other enterprise documentation tools Competence in reporting tools and dashboard creation (Excel, Power BI preferred) Excellent communication and collaboration skills

BMR Review, BPR Review, Line Clearance, Change Control, Deviation.

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech Transfer Department Documentation. M. Pharma in Pharmaceutics Proficiency in MS- Word, Excel, PowerPoint Perks and benefits :- As per Company Standard

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Work Experience 12 to 15 years of experience in Pharma Vendor Audit Management 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3. To execute vendor Audits, CAPA tracking, and qualification documentation 4. To schedule and monitor the Vendor Audits 5. To work on VQ special projects in coordination with Project IT team 6. To track the project till its implementation and Go Live across all sites Technical , behavioral & managerial 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 5. Result Orientation 3. Customer Centricity Education Masters in Pharmacy Post Graduation in Science or Chemistry

Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic impurities. Harmonization of Cleaning and validation procedures across all sites of Lupin. Work Experience 10-12 years Education Masters in Science Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Job Description Batch Manufacturing and Filling activity. Batch manufacturing experience of Solution, Emulsion, suspension and gel eye drop products. Preparation and review of Deviation investigation, Risk Assessment, Impact Assessment, Equivalency reports, URS and various other production related documents and monthly intervention reports. Responsible for audit preparation (Internal and regulatory) and compliance. Reconciliation of product at various stages of batch manufacturing and filling. Preparation and reviewing of SOP and compliance after implementation. QAMS related activity. Approved GMP trainer for provide training to team members. Preparation of Media fill BMR. Planning for production activities by coordinating with PPIC, PDL, Engineering, validation and QA. Work Experience 8 to 10 Years Education Graduation in Pharmacy Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management

JOB RESPONSIBILITIES : [A] Regulatory Compliance : 1. To co-ordinate with corporate regulatory department for submission of documents as part of filing of DMF, updating and response to queries to US, Europe, China, Japan, Korea and Rest of World market. 2. To co-ordinate with various department for the timely submission of documents and its compliance. 3. Coordination with quality control, analytical development lab (ADL) and corporate validation Lab (CVL) for specification and standard test procedures. 4. Coordination with CQA for document preparation and implementation. 5. Keep the track of technology/Analytical Method transfer and other documents received from ADL and R&D. 6. Responsible for co-ordination during regulatory inspections and customer audits. Responsible for co-ordination with all stake holders for appropriate action plans for the corrective and preventive actions (CAPA) and timely closure. 7. Review and approval of stability summary report and handling of stability failures. Responsible for timely communication with corporate regulatory department on the stability failures for further actions with regulatory agencies and customers. 8. Responsible for the co-ordination with QC and other agencies for the timely qualification of working reference standards (WRS) of APIs, intermediates and impurities. 9. Responsible for the management of Skip Testing and associated documents. 10. Responsible for ensuring compliance of products against monograph specification. 11. Review and approval of analytical raw data before the regulatory submissions for filing. [B] Validation. 1. Responsible for review and approved of Process Performance Qualification protocols and reports through Documentum system. 2. Responsible for review and approved Cleaning Validation and Verification protocol and report through Documentum system. 3. Ensure compliance of validation master plan. A. Batch release and Dispatch: 1. Responsible for batch release, Certificate of analysis and material dispatch related activities. 2. Responsible to communicate the business development and PPIC in case of any delays in the dispatches due to any reasons. B. QMS: 1. Responsible for Handling of Market complaint, returned goods and Recall activities. C. Product review: 1. To ensure preparation, review & approval of Annual Product Quality Review (APQR) as per scheduled timelines in coordination with other departments. D. Audit and Compliance: 1. Responsible for audit preparation, compliance and response to regulatory and customer. 2. Responsible for Retain sample management of APIs & Saleable Intermediates. 3. Perform internal audits within Alembic site. E. Customer Support/ Compliance: 1. Co-ordinate with Production, QC, supply chain, logistic, purchase and Marketing department for dispatch related activities and customer queries. 2. To support the business development team during the development of new customers by providing required information as part of questionnaire assessment and Technical quality agreement. 3. Coordination with quality control for specification, standard test procedures and QC related queries generated by customers. 4. Handling of CAPA & Change control activities for implementation, monitoring and assessment. 5. Review and approval of documents in DCS/Documentum. 6. Any other task assigned by QA Head.

Responsibilities: * Conduct BPR reviews, change control procedures & equipment validation. * Ensure compliance with industry standards through quality assurance processes.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Qualification : B.Pharma Experience : 3 to 10 yrs. Designation : Officer Salary Range : 6 to 7 Lacs PA. Unit : Injectable Kindly Find the JD. Management of Aseptic Process Simulation (Media Fill) Program. Review of quality systems such as Change Control, Deviations, CAPA, OOS, OOT, LIR, Market Complaint, FAR, Product Recall and other QAMS documents. Preparation and Review of APQR. Nitrosamine Risk Assessment of Drug Product Preparation and review of site QA SOP and review of cross-functional department SOP. Review of Batch Manufacturing Record and Batch Packing Record. Preparation, review and execution of hold time study of drug product. Preparation and review of thermal cycling and temperature excursion study If interested mail cv at :- neetij@selectsourceintl.com

Role & responsibilities Job Summary We are seeking an individual for the Quality Control Microbiology team, responsible for review and approval of microbiology analytical data/record, review of EM and water trend, monitoring of aseptic process simulation. Review and approval of Analytical method validation related to Microbiological test. This role includes the participation into investigation related to Microbiology Roles & Responsibilities Responsible for Review and release of Microbiological Tests (Environmental Monitoring, Water Testing, Microbial Limit Test, Sterility Test and Bacterial Endotoxins Test). Responsible for review and Approval of Microbiological testing data/ Master data in LIMS. Handling of QMS elements like change control, Incident, OOS, OOT and CAPA related to Microbiology. Responsible to carry out the investigations related to Microbiology and timely closure of the same within the defined timeline. Review and approval of SOPs, protocols and reports related to Microbiology. Ensuring the compliance of Audit observations related to Microbiology. To review trends as applicable and to recommend any changes for the better control of the system. To review and approve STPs, Specifications, preparation of record of analysis and analytical test report. To ensure cGLP activity in lab and compliance in Microbiology laboratory. Responsible for the Monthly audit trail review of Instrument /Equipments related to microbiology. Responsible for the review and approval of Analytical method validation with respect to Microbiology. Monitoring of Media Fill/ Process Simulation and review of media fill protocols and reports. Educational qualification: A Master degree in Microbiology, or a related field. Minimum work experience : 5 to 8 years of experience in Pharmaceutical Microbiology / Quality assurance or a similar role Skills & attributes: Technical Skills • Knowledge of microbiology and aseptic practices and Aseptic Process simulation activities and disinfectant validation and handling of Microbiological Cultures. • Skilled in review of Microbiological data, EM, water and compressed air trends. • Review of EM and water trends, trends, Handling of Microbiological Culture. Behavioural Skills • Attention to detail in performing line clearance, verification, and record reviews. • Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities. • Communicates effectively with team members and stakeholders regarding batch-related activities and compliance. • Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification. • Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.

Job Summary We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards. " Roles & Responsibilities You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance. You will be responsible for executing or assigning the execution of batch records and log books, filling in various applicable formats, including line clearance and sampling formats, along with batch records review sheets. Your tasks also involve reviewing the records maintained by the Production team, creating additional records as needed, conducting all documentation with respect to Quality Assurance (QA) activities, ensuring that documentation is happening online, and follow the incident reporting system in the case of deviations. You will be responsible for issuance, availability, and adherence of approved procedures to the manufacturing team. You will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor. Your responsibilities also include verifying whether the manufacturing facility meets basic Good Manufacturing Practice (GMP) requirements at all times, including facility upkeep, environmental conditions, segregation of materials, and status labeling. In case of deviations, you will follow the incident management process. You will provide essential support to the supervisor in conducting investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT) results, incidents, etc. by collating data and conducting interviews. You will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time. You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records. You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed. " Qualification Educational Qualification A B.Pharm. or Post-Graduation (Life Sciences) Minimum Work Experience 4 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development Skills & Attributes Technical Skills: A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization. In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs. Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities. Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market. Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements. Ability to understand and implement organizational policies and ensuring compliance. Behavioural Skills: Demonstrates a commitment to continuous learning. Strong communicating and influencing skills. Displays analytical and logical thinking abilities. Is self-motivated and takes initiative. Adaptability to the work environment, along with being a team player. Ability to go beyond boundaries, showcasing a proactive and innovative approach. " Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon... " Benefits Offered At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards... " Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions... For more details, please visit our career website at https://careers.drreddys.com/#!/ "

Job Summary We are looking for an individual for the SIT Team to oversee the investigation of major and critical deviations, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the DCMS deviations log, and providing support during regulatory inspections. Roles & Responsibilities • You will be responsible for overseeing the investigation of major and critical deviations from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports. Your will also be working on the trending of the deviations and identification of adequate action items for reduction of the same. • Your role involves active participation in investigating OOS (Out of Specification) and other relevant cases, working closely with CFT members to determine root causes, CA, PA, and report writing. • You will review minor and critical , providing constructive feedback for improvement. • Your responsibilities include periodically assessing the trending of minor deviations, highlighting or escalating key observations, regularly reviewing the deviations log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports. • You will offer necessary support to the site in readiness for or during regulatory inspections related to investigations. Qualification Educational qualification: A Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline Minimum work experience : 7 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance Skills & attributes: Technical Skills • In-depth knowledge and experience in overseeing investigations, and familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA). • Expertise in investigating valid OOS and other relevant cases. • Familiarity with reviewing deviations / OOS log and ability to perform classification of data. • Ability to craft comprehensive investigation reports. • Experience in providing necessary support for regulatory inspections related to investigations. • Knowledge of regulatory requirements pertaining to deviations investigations. Behavioural Skills • Ability to collaborate closely with CFT members. • Analytical mind set for identifying root causes and developing effective solutions. • Strong problem-solving skills and attention to detail in reviewing deviations, reports, and trending data and implementing corrective actions. • Effective communication skills for report writing and escalation of key observations. • Commitment to ensuring compliance with regulatory requirements in investigations. • Ability to offer necessary support to the site in readiness for or during regulatory inspections. Additional Information looking someone with strong QC Microbiological investigation background. Should have exp in Microbiological compliance. Education :M.Sc. Microbiology Exp : 8-10 Years Industry : Injectable preferred/ OSD will be second preference Person will be responsible to manage 3 sites Microbiological compliance at Baddi

Immediate joiners are preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com 1.To review and implement Quality Management System for cGMP compliance at site. 2.To review and approve of product design. 3.To review and approval of production and quality control documentation for compliance with GMP and GLP requirements. 4.To Handle Caliber BRM, QAMS, DMS, Nichelon 5 CMS, E-logbook, E-schedule, Microsoft Dynamic, NCR 5.To review and approve SOPs, Validation Protocols, Master Batch Production Records and other related documents at site. 6.To review and approve Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 7.Approval signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations, Stability Protocols, and other Master Documents. 8.Vendor Assessment. 9.Handling of OOS. 10Process validation and equipment cleaning validation. 11.To review batch production Records and Analytical documents, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated, documented and authorized. 12.To export certification for batches intended for exports. 13.To release (approval or rejection) the batch manufactured at site. 14.To monitor qualification, validation and requalification activity at site. 15.To trend the data and analyses the trend. 16.To Prepare and approve Annual Product Quality Review for drug substance / drug product quality, Recommend the area of improvement, as applicable. 17. To investigate market compliant. Review response. 18.Handling of product recall. 19.To review Product License Application and support Regulatory department for obtaining the product license from the local Regulatory Authority. 20.To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product. 21.To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit.

Job Description Conduct all tasks/ activities as per the applicable SOPs. Report any difficulty or deviation in the procedures/instructions to immediate Supervisor/Managers. Report any quality concerns or suggestions for improvements to Supervisor/ Managers.Preparation and Review of Quality Assurance SOP’s. Review of other departments SOP’s. Review of Master Documents such as BMR/BPR, Test batch monitoring protocols / process validation protocol and reports etc. Initiation and log in of Quality System document such as Deviation, Change Control, OOS, OOT, market complaint, Annual product review and Non conformities. Work Experience 3-5 Years Education Graduation in Pharmacy Competencies

THE POSITION: We are looking for a Data entry Analyst to update and maintain Pharmaceutical global tenders’ information. ESSENTIAL DUTIES AND RESPONSIBILITIES: Data Entry responsibilities include collecting and entering data in databases and maintaining accurate records. Compile, verify accuracy and sort information according to priorities to prepare source data Review data for deficiencies or errors, correct any incompatibilities if possible Research and obtain further information from documents Store completed work in designated locations and perform backup operations Comply with data integrity and security policies They can perform repetitive tasks with a high degree of accuracy in an ever-changing working environment. MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: Basic to Advance Excel skills. Understanding of Tenders preferably pharma tenders Literature reading for complicated documents. Pharma knowledge is preferred