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5.0 - 10.0 years
7 - 12 Lacs
Bengaluru
Work from Office
As a QA (Quality Assurance) /Test Developer you will be designing better ways to identify potential weak spots, inefficiencies, and issues within software systems. This position will work closely with development teams and other test engineers in the implementation and delivery of software products that meet rigorous quality standards, budgets, and timelines. You will play a key role by delivering quality functions for development teams within test driven framework. Your scope will include Test Plan Development, Test Case Execution, Automation Testing, Data Creation, API Validation and incorporating test automation in the CI/CD pipelines. Your primary responsibilities include: Selenium Test Automation Proficiency: Have experience with Selenium test automation. JAVA Proficiency: Possess knowledge with JAVA programming language. API Testing and Automation Familiarity: Hands-on experience in API testing and API automation. Agile Development Methodologies: Familiarity with agile development methodologies. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 5+ years of experience. Test Planning and ExecutionDevelop comprehensive test plans and execute test cases to ensure software products meet quality standards and requirements. Automation IntegrationImplement and integrate test automation into Continuous Integration/Continuous Delivery (CI/CD) pipelines to streamline testing processes and enhance efficiency. Collaborative DevelopmentWork closely with development teams to identify potential weak spots, inefficiencies, and issues within software systems, fostering a collaborative approach to software quality. Quality AssuranceDeliver quality functions for development teams, supporting test-driven development frameworks and ensuring rigorous quality standards are met throughout the software development lifecycle. Excellent Problem-Solving Skills: Demonstrated experience in problem-solving, with the ability to tackle complex issues and find effective solutions. Preferred technical and professional experience Automation FrameworksProficiency with API testing and API automation in other Automation frameworks, such as Playwright etc. Cloud/Container skillsFamiliarity with cloud and container technologies, including Docker, Kubernetes, Red Hat OpenShift, etc. Programming LanguagesJavaScript, Jenkins, Linux, and Unix environments.
Posted 1 month ago
8.0 - 12.0 years
6 - 13 Lacs
Mahad, Raigad
Work from Office
Role & responsibilities RESPONSIBILITIES Product is maintained in constant state of validation Product history is documented and available and current since transfer from development to date Continuously improving CpK (process capability)/ Ppk (Process Performance) Degree of standardization of product process. Genotoxic and elemental impuirty assessment in all APIS Nitrosamine impuirty assessment Transport risk assessment Investigation and data analysis of Customer Complaints, Recalls, Recurring Deviations and OoS, OoE Out of Specification, Out of Expectation. Success rate of Health Authorities inspections. Completeness of Reg CMC dossier Effective CAPA. Continuously improving Yield. Technical reports executed on time and with the right expectations. Preferred candidate profile Transfer OUT process Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed. Investigations/improvement on product Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritised and monitored Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters Validation: Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications / Annual Monitoring Batches, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts Approves both Validation Protocols and Report Testing Monograph oversight: Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content Change control: Ensure oversight of technical changes and lead end- to- end change control management related to technical issues, working cross- functionally as required. Training: Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position Regulatory Filings: Act as the interface for the site with the relevant Health Authorities for technical issues. Review and releases regulatory proposals or information required for regulatory filings. Genotoxic impuirty assessment, Nitrosamine impuirty assessment, Elemental impuirty assessment and Transport risk assessment report. Audit support: Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit Key process safety related roles and responsibilities Responsible for the safe operation of one or more processes and the appropriate training of the operators in the process. Facilitate team which carries out ZHA before introducing the process. Prepare overall plan for Integrated Management System documentation, control and its implementation within the department in close coordination with respective HODs including implementation of Olon Health, Safety & Environment system as per CHSE guidelines. As appropriate, responsible for implementation of, compliance to and governance of practices specifically prescribed to this role by the Novartis Manufacturing Manual. Perks and benefits
Posted 1 month ago
6.0 - 10.0 years
6 - 7 Lacs
Vapi, Dadra & Nagar Haveli, Daman & Diu
Work from Office
1. Quality Management Systems: Implementing, monitoring, and maintaining Quality Management Systems to ensure compliance with CGMP/regulatory guidelines. 2. Documentation: Reviewing and approving technical and quality documents. Required Candidate profile Should be minimum Post Graduation in Science having the work experience of about 6-7 years of experienced in FMCG company or in pharma industry.
Posted 1 month ago
3.0 - 6.0 years
3 - 6 Lacs
Vapi, Dadra & Nagar Haveli, Daman & Diu
Work from Office
Developing and Implementing QA Systems and Procedures: Responsible for establishing and maintaining quality assurance systems, policies, and procedures. This includes creating SOPs (Standard Operating Procedures), work instructions. Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.
Posted 1 month ago
8.0 - 10.0 years
7 - 9 Lacs
Pune
Work from Office
Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence
Posted 1 month ago
1.0 - 5.0 years
3 - 5 Lacs
Vapi
Work from Office
Walk-In Interview Date : 22nd June 2025 (Sunday) Timing : 9.00 AM to 1.30 PM Venue : Umedica Laboratories Pvt, Ltd. Plot No 221,221/1 II Phase GIDC Nr Morarji Circle, Vapi 396195. 1. Tablet Manufacturing Department: Ability to handle process like Dispensing, Granulation, Compression, Coating, SOPs preparation, well versed with ALCOA & GDP principles. QMS Manufacturing investigation (OOS/OOT/Deviation/CAPA),Training.) Position: Officer to Sr. Executive Qualification: M.Sc. / B.Pharm / M.Pharm No. of Vacant Position: 20 Experience: 2 to 8 years To Operate Granulation lines (RMG/FBD/FBP/Roll Compactor), Automatic Compression Machine (PLC/SCADA based Cadmach & Fluid Pack), Coating (Kevin & Gansons) Position :Technical Associates (Operator) Qualification: ITI / Diploma /BSc Experience: 1 to 5 years No. of Vacant Position: 15 2. Tablet Packing Department: Should have sound knowledge in SOPs, BPR, Line Clearance, Daily formats &records, Manpower Handling GDP, GMP. Position: Officer to Executive Qualification: B.Pharm / M.Pharm / MSC No. of Vacant Position: 15 Experience: 2 to 8 years To Operate Blister Pack Machine ELMACH 3015 PDA machine/ IC 150C / WKH100 Cartonator machine/ Track and Trace machine with Temper Evident., CVC Primary & Secondary) Position: Technical Associates (Operator) Qualification: ITI / Diploma /BSC Experience: 2 to 5 years No. of Vacant Position: 15 3. Injectable Department: (Should have sound knowledge require in SVP, Aseptic Vial & Ampule filling, Washing, Autoclave & Sterilization. .) Position: Officer to Sr. Officer Qualification: B.Pharm / M.Pharm / BSC/ MSC Experience: 1 to 7 years No. of Vacant Position: 10 4 . Quality Control Department: Candidates having educational qualification of BSc/MSc with specialization in Chemistry. Organic chemistry/Analytical chemcistry with experience of 2 to 7 years in Quality control departments. Working exposure in HPLC, GC, UV Vis spectrophotometer, FTIR, Melting point, Dissolution Apparatus etc with regulatory exposure of USFDA/MHRA/EU/Brazil ANVISA/TGA/WHO audit. .) Position: Officer to Executive Qualification: B.Pharm / M.Pharm / BSC / MSC . Experience: 1 to 7 years No. of Vacant Position: 15 5. QA Department: (Should have sound knowledge in, Audit Trial, QMS , Training, SOP Preparation , IQPA Activities & Process Validation Position: Officer to Sr. Officer Qualification: B.Sc / M.Sc. / B.Pharm / M.Pharm Experience: 1 to 6 years No. of Vacant Position: 05 6. TTD Department: Preparation of plan regarding transfer of process / product from development, scale-up, manufacturing of exhibit / submission, launch to post approval phase which shall encompass the quality aspects (including risk assessment principles) and necessary regulatory requirement aspects. Co-ordination between R & D / client (product transferring unit) and all applicable stake holder departments in the plant (receiving unit) so as to ensure the smooth and effective transfer of product. Position: Officer to Sr. Officer Qualification: B.Pharma / M.Pharma Experience: 1 to 6 years. 7.Warehouse Department: (Should have sound knowledge in SAP, Handling of Qms Activity , handling of Purchase order, Purchase Requisition, GRN, RM, PM activities. Position: Officer to Sr. Officer Qualification: / B.com / M.com / B.Sc No. of Vacant Position: 02 8.Packaging Development Department: (Should have sound knowledge in Art Work & Product Design) Position: Officer to Sr. Officer Qualification: Diploma /B.E - Printing & Packaging Technology No. of Vacant Position: 02 Kindly carry below listed documents during interview. 1. Latest Passport size photo 2. Latest updated resume 3. Xerox copy of Qualification Certificates 4. Salary Slip / Appointment letter copy of current company / CTC Proof
Posted 1 month ago
2.0 - 4.0 years
4 - 6 Lacs
Medak
Work from Office
Job Description Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Responsibilities Qualifications Bachelors degree
Posted 1 month ago
4.0 - 8.0 years
6 - 10 Lacs
Mumbai
Work from Office
The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take the lead and well give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities. For our business, for clients, and for you The Role: Understand the global outsourcing policy and framework and support the Global Outsourcing Team in ensuring the business comply with this and supporting in annual refresh of policy and process. To join regular calls and meetings with the Global Outsourcing Team to shadow and learn the business and operating model from an outsourcing perspective. Support the regulated businesses across Apex with maintenance of the Nexus Assurance Navigator system. Take responsibility and ownership of Nexus Navigator and validation and integrity of data within. Work with various technology stakeholders across the business to ensure there is accurate and seamless data feeds and support with development of reporting in and out of the platform. At as project manager for any system, data or reporting projects and initiatives Support the regulated businesses across Apex with Outsourcing tasks within the platform Perform analytics on data outputs Create reports from excel outputs and support with development of dashboards to present data Support the India Outsourcing Lead, GSC and local businesses with maintenance of the Nexus Assurance Navigator system and to support with preparation of reports. Support the India Outsourcing Lead and Local MGT with amending, preparing and reviewing outsourcing spreadsheets Support the India Outsourcing Lead and Local MGT with signing of all outsourcing documents and uploading into the system Support with Nexus Assurance on-going development and system enhancement projects. Act as super user on Nexus, providing support globally and over time supporting with delivering training and guidance on the system Support with various outsourcing projects with internal stakeholders. Maintaining outsourcing registers in excel and on systems. Preparing and presenting quarterly and ad-hoc reporting packs. Assisting in audits including internal audits and risk assessments and reviews from an outsourcing perspective. Maintaining and updating trackers internally and ensuring data integrity and confidentiality of internal information. Be a member of the Global Outsourcing working group and take part in joining each of the initiatives/project teams that this group are tasked with. Preparation of annual due diligence reports Quality assurance and control The Skills: Strong communication and drafting skills including drafting of presentations and reports and supporting in writing policies and procedures Ability to learn and grasp new compliance/risk/regulatory concepts and understanding these across multiple global jurisdictions within the business. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Very strong MS Office skills (including MS Excel Outlook, MS Word, MS PowerPoint) DisclaimerUnsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.
Posted 1 month ago
2.0 - 5.0 years
3 - 5 Lacs
Kolkata, India
Work from Office
Roles and Responsibilities: Conduct internal audits across multiple FMCG locations, ensuring compliance with company policies and controls. Analyze sales transactions, accounting entries, and GST records to ensure accuracy and regulatory adherence. Utilize SAP for data extraction, validation, and audit trail analysis. Prepare audit reports with detailed observations, root-cause analysis, and actionable recommendations. Collaborate with cross-functional teams to ensure timely resolution of audit findings. Key Requirements: 2–3 years of relevant audit experience in the FMCG sector. Sound understanding of sales processes, accounting standards, and GST compliance. Proficient in SAP and MS Office, especially Excel, for analytical review and reporting. Excellent communication and report-writing skills. Willing to travel extensively (10–12 days per month) for field audits across various regions.
Posted 1 month ago
3.0 - 6.0 years
3 - 7 Lacs
Bengaluru
Work from Office
Develop thorough test plans and document the results and progress Develop in-depth functionality and stability automatic tests that will map customer use cases Research the right set of workloads and benchmarks Develop automated test scenarios and environments for End2End automatic evaluation Collect test evidence measurements to ensure system functionality, stability and scalability Establish automatic measures to assess the accuracy Analyze results to find ways to improve functionality coverage Analyze root causes and identify areas for improvement Collaborate with development teams to drive resolution for issues and improvement Generate test automation summary reports for stakeholders review Required education Bachelor's Degree Preferred education Bachelor's Degree Required technical and professional expertise 3-6 years of test automation development experience 2-4 years of experience in software testing in the workplace 2-4 years experience in Python/Go/Java programming Good English communication skills (written and oral) and be able to work independently and as part of a team. Knowledge of REST technologies is an important advantage. Preferred technical and professional experience Cloud network concepts including software defined networking, virtual private cloud (VPC), network services such as load balancer, firewall, gateway as it fits in cloud network infrastructure Working knowledge of cloud network infrastructure technologies Linux network internals Linux Virtualization technologies relating to network virtualization Kubernetes, Docker Knowledge of bash, go lang, php, awk Working knowledge of Network tools is an important advantage. Knowledge of Windows and Linux operating systems Knowledge of Github and Jira is an advantage. Fast learner and a team player
Posted 1 month ago
0.0 - 2.0 years
1 - 5 Lacs
Hyderabad
Work from Office
Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle.
Posted 1 month ago
2.0 - 7.0 years
0 - 0 Lacs
Hyderabad
Work from Office
Dear All, We are conducting Walk-In Interview on 13th June 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: AQA - 6-8 Years of experience in Analytical QA IPQA - 2-4 Years of experience in Line Clearance activities for Production, Warehouse and Dispensing of Raw Materials Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, HPLC and Dissolution instruments Microbiology - 2-3 Years of experience in Environmental monitoring, Culture media preparation and MLT testing Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100
Posted 1 month ago
10.0 - 15.0 years
10 - 15 Lacs
Bilaspur, Uttar Pradesh, Uttar Pradesh, India
On-site
Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc. Responsible for review and approval of all continual improvement projects affecting quality at a site Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. Development and monitoring of corrective action plans where needed Ensuring quality support to regulatory affairs as it relates to updates/changes to market authorizations Review of all documentation (i.e. LIR, OOS, Change Controls, etc.) Ensuring quality interface with internal and external customers when dealing with activities such as service requests, issue resolution, complaints, product information, or for movement of materials, products, or process from site to site Responsible for management of regulatory authority and other external compliance audits (e.g. Customer audits) including communication, tracking and resolution of observations. Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies Responsible for Performing, reporting of observations and verification of compliance reports of internal audit
Posted 1 month ago
5.0 - 10.0 years
5 - 10 Lacs
Bilaspur, Uttar Pradesh, Uttar Pradesh, India
On-site
24 7 audit readiness Exposure in Wet Chemistry & responsible to works in different shifts Perform the raw material analysis & wet lab activity by using the technique (KF, pH, KFC, UV, FTIR, SOR, Oven, Auto titrator, Polari meter & TLC) etc. Sampling of Raw material / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms Perform analytical test according to the monograph and SOP & follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory Participation in internal, external, regulatory audits & Ensure 100% participation in training s against CAPA s Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge Responsible for calibration and verification of instruments & maintaining of reserved samples room and chambers Must be ensured sampled, approved, and rejected labels timely as required & responsible to maintain the stock record of chemicals and reconciliation of standards Determining team priorities in accordance with the plant s needs, while coordinating with the team leader/Manager.
Posted 1 month ago
2.0 - 6.0 years
1 - 5 Lacs
Hyderabad
Work from Office
Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle.
Posted 1 month ago
3.0 - 5.0 years
3 - 6 Lacs
Tirupati, Jharsuguda, Vallam
Work from Office
Sr. Executive AM- Hot Refining: CMR GreenTechnologies Limited CMR Group is India's largest producer ofAluminium and zinc die-casting alloys. With 13 state-of-the-art manufacturingplants across the country, CMR has become the preferred supplier for many ofIndias largest automotive industry leaders. Since its inception in 2006, CMRhas consistently outpaced competition by focusing on delivering superior valueto its stakeholders. This value is driven by a strong commitment to technicaladvancements, quality enhancement, sustainability, and people-centric practices.We believe in an " Employee First " philosophy, ensuring that our people are at the core of our success. Our dedication tofostering an enriching work environment is reflected in our recognition asthe 'Most Preferred Place for Women to Work' and as one ofthe Top 25 Mid-Sized Indias Best Workplaces in Manufacturing for 2025 by GreatPlace to Work. As CMRcontinues to chart its growth trajectory, we remain committed to innovation andexcellence. We are always looking for enthusiastic and dynamic individuals tojoin our team and contribute to our continued success. Position : FLO- Hot Refining Location: Tirupati , Vallam , Orissa Job Band : A Designation : Sr.Executive/AM. No.of Posts : 2 Reporting to : Area Head - Hot Refining Qualification: Essential Candidateshould have full time degree or Diploma in Mechanical / Electrical / Metallurgyor a related field form any reputed institution. Desirable Degree/Diploma/Certification Course in Operation / General Management. Experience: Essential 3 to 5 years ofexperience in a hot refining or similar role within the refining ormanufacturing industry. Desired Strongunderstanding of refining processes and technology. Experiencewith process optimization and quality control in a refining environment. Excellentproblem-solving skills and the ability to troubleshoot complex technicalissues. Knowledgeof industry standards for refinery operations. Job Profile: Responsiblefor ensuring minimal deviation from " Process Monitoring Sheet " Overseehot refining operations of operators such as - Charging schedule, Fluxquantity, Alloying composition and addition of virgin alloy material etc.across Furnaces. Ensuresshift cost control, production, melt loss, dross production, recovery andquality targets Responsiblefor Quality report sign of basis spectrometry and visual checks, as well as ERPbooking Respondsto issue escalations during shift Coordinateswith maintenance to ensure availability of machine/equipments and smoothoperations during the shift Controlcorrection Ingotquality control and also control weight variation of ingots. Controlplant pollution Followall process parameter during process. CoreCompetencies: Qualitystandards Effectivecommunication Knowledgesharing and learning. ResultOriented. PreferredSkill :- Experiencewith implementing new technologies in a refinery setting. Knowledgeof environmental regulations and sustainability practices in refining. General Age-27- 30 years. CTC 3LPA to 6.5 LPA approx. Candidateshould not be frequent job changer. NoticePeriod- Joining period Max 30 Days. We can buy notice period, if required Location: Vallam: G 108/2, SIPCOT Industrial Park, Vallam Vadagal, Kanchipuram District, Vallam, Tamil Nadu 631604 Tirupati: Survey No. 429-434, APIIC Industrial Park, Chinthalapalem Village, Yerpedu Mandal, Tirupati District, Andhra Pradesh 517619 Orissa: Plant Survey No. - 2020-2027, 1991-1993, Village Derba, Tehsil Rengali, Dt. Sambalpur, Odisha 768212
Posted 1 month ago
8.0 - 10.0 years
6 - 10 Lacs
Noida, Hyderabad, Bengaluru
Work from Office
Req ID: 309049 We are currently seeking a QA - Core Banking Data migration to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Job TitleQA Data Migration "“ Core Banking (Transact) : We are looking for a highly skilled Quality Analyst with expertise in the banking sector, specifically in Core Banking (Transact) along with migration experience. The successful candidate will be responsible for ensuring the quality and integrity of data during migration from legacy systems to new platforms. Key Responsibilities: Develop and execute test plans, test cases and test scripts to ensure data integrity, accuracy and completeness during migration. Work across multiple functional projects to understand data usage and implications for data migration. Identify, Document and track data quality issues and collaborate with cross functional teams to resolve them. Validate data migrated to new systems, ensuring it meets business requirements and free from defects. Identify, report and track defects found during testing and collaborate with development teams to resolve them. Skills and Qualifications: 8-10 years of overall experience with a minimum of 3+ years as Core banking QA. Proven experience as a Quality Analyst in the banking sector. In-depth knowledge of Core Banking Transact and migration processes. Familiarity with agile methodologies and project management principles. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Ability to work independently and as part of a team.
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
Jhagadia, Ankleshwar
Work from Office
JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 17) To be controlled all master documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products. 20) Preparation of documents for Certification & product registrations work i.e. FDA, Halal, Kosher, Reach. etc. Review specification, test procedure and SOP's for their deficiencies according to audit points 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per senior’s guidance. 5) To be prepare cleaning validation protocol and report as per senior’s guidance. 6) To be conduct training and evaluation done as per Schedule. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 13) To be prepared data for monthly report as per QMS and submit to senior. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products.
Posted 1 month ago
5.0 - 10.0 years
5 - 9 Lacs
Ahmedabad
Work from Office
Maintain QMS & ensure compliance with GMP standards across the plant Conduct audits, compile reports, approve vendors for RM & packaging Review documentation like SOP, BMR, BPR, APQR, etc Handle deviations, complaints, OOS reviews, and implement CAPA Required Candidate profile Experience facing audits in the pharma intermediates/API/bulk drug industry only; formulation experience not relevant Excellent communication skills for audits. Fluency in English & MS Office.
Posted 1 month ago
4.0 - 6.0 years
3 - 6 Lacs
Medak
Work from Office
1.0 Job Responsibilities 1.1 Preparation and review of SOPs. 1.2 Handling of QMS documents- Change controls, Deviations, Incidents, OOT, CAPA and OOS. 1.3 Handling of Market Complaints, Return goods & Product recalls. 1.4 Review of RM, PM, IP and FP specifications and STPs. 1.5 Preparation and review of Calibration Certificates, COAs. 1.6 Review of Analytical Raw data. 1.7 Review of analytical method validations. 1.8 Responsible for Vendor management- Review of Vendor development documents and approval process. 1.9 Handling of regulatory inspections. 1.10 Audit compliance.
Posted 1 month ago
1.0 - 2.0 years
5 - 9 Lacs
Patiala
Work from Office
Overview Conducting quality checks of RM/PM material received in the plant to ensure that all FLI standards of quality are met. Monitoring RM/PM tests, reporting of non-compliance of service providers and communication about the corrective action. Maintaining accurate and comprehensive reports for communication to all the people concerned. Conducting regular audits of RM/PM stores for storage condition and FIFO/FEFO implementation. Ensure the smooth implementation of food safety policies at plant. 2) Ensuring best quality of RM/PM received in through quality checks and inspection. 3) Implementing right quality control systems/standards for the vendors / suppliers. 4) Responsible for ensuring the maintenance of implementation of GMP, GHK GLP and internal / external audits (HACCP, AIB, Personal Hygiene, Process audit) at Plant. 5) Communication to vendors in relation to the Root cause and failure analysis for deviations and follow up for the implementation of the corrective actions. 6) Ensure receiving of quality RM/PM material as per the FLI standards. Reporting of Deviation/Discrepancies to vendors/purchase and follow-up for the corrective and preventive steps. Responsibilities Accountabilities list in priority order the main accountabilities/deliverables of the role, including key measures. These should be clearly the responsibilities of the JOB HOLDER. Conducting quality checks of RM/PM material received in the plant to ensure that all FLI standards of quality are met. Monitoring RM/PM tests, reporting of non-compliance of service providers and communication about the corrective action. Maintaining accurate and comprehensive reports for communication to all the people concerned. Conducting regular audits of RM/PM stores for storage condition and FIFO/FEFO implementation. Ensure the smooth implementation of food safety policies at plant. 2) Ensuring best quality of RM/PM received in through quality checks and inspection. 3) Implementing right quality control systems/standards for the vendors / suppliers. 4) Responsible for ensuring the maintenance of implementation of GMP, GHK GLP and internal / external audits (HACCP, AIB, Personal Hygiene, Process audit) at Plant. 5) Communication to vendors in relation to the Root cause and failure analysis for deviations and follow up for the implementation of the corrective actions. 6) Ensure receiving of quality RM/PM material as per the FLI standards. Reporting of Deviation/Discrepancies to vendors/purchase and follow-up for the corrective and preventive steps. Qualifications B.Sc/ B.E./B.Tech/M.Sc - Food Technology B.Sc/ B.E./B.Tech/M.Sc - Food Technology Accountabilities list in priority order the main accountabilities/deliverables of the role, including key measures. These should be clearly the responsibilities of the JOB HOLDER. Conducting quality checks of RM/PM material received in the plant to ensure that all FLI standards of quality are met. Monitoring RM/PM tests, reporting of non-compliance of service providers and communication about the corrective action. Maintaining accurate and comprehensive reports for communication to all the people concerned. Conducting regular audits of RM/PM stores for storage condition and FIFO/FEFO implementation. Ensure the smooth implementation of food safety policies at plant. 2) Ensuring best quality of RM/PM received in through quality checks and inspection. 3) Implementing right quality control systems/standards for the vendors / suppliers. 4) Responsible for ensuring the maintenance of implementation of GMP, GHK GLP and internal / external audits (HACCP, AIB, Personal Hygiene, Process audit) at Plant. 5) Communication to vendors in relation to the Root cause and failure analysis for deviations and follow up for the implementation of the corrective actions. 6) Ensure receiving of quality RM/PM material as per the FLI standards. Reporting of Deviation/Discrepancies to vendors/purchase and follow-up for the corrective and preventive steps.
Posted 1 month ago
3.0 - 6.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Responsibilities: Review of formulation development documents like trade dress for new product, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report. Health insurance Provident fund
Posted 1 month ago
8.0 - 13.0 years
10 - 15 Lacs
Mumbai
Work from Office
Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.
Posted 1 month ago
8.0 - 10.0 years
7 - 9 Lacs
Pune
Work from Office
Long Description 1 Exposure to perform the testing of Inprocess, Finished product, Stability and Cleaning validation samples etc. 2 Having knowledge of Analytical Instruments to perform the testing by HPLC, GC, UV, IR, KARL FISCHER etc. 3 Having Analytical testing skills to perform the MDI/DPI Products test like Assay, APSD, DDU, RS, Spray Pattern, FPM and physical testing etc. 4 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation. 5 Exposure of Stability sample management & Regulatory Audits. 6 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 7 Knowledge of GLP and Good documentation Practices. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Pharmacy Work Experience 5 to 8 years
Posted 1 month ago
5.0 - 10.0 years
6 - 9 Lacs
Alathur, Chennai
Work from Office
Role & responsibilities QMS handling like change control, deviation, OOS, Investigation, CAPA, etc., QMS trending. Handling site QA documentation Issuance, distribution and archival of documents. Document storage management. Handling compliance wire, document management system software, track wise, SAP etc. Collaboration with cross functional team. Providing training Preparation of SOP, protocol, reports etc. Knowledge in overall API QA function. Internal audit experience will be added advantage. Participated in USFDA regulatory inspection and arrange necessary documents as needed on timely manner. Preferred candidate profile Looking only female candidates for this opening. Ready to relocated chennai location
Posted 1 month ago
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