271 Process Validation Jobs - Page 5

We are looking for an experienced and detail-oriented Quality Assurance (QA) professional to oversee and maintain the quality management system and ensure compliance with statutory and customer standards. Responsibilities: Prepare and maintain all quality manuals, process documents, and standard operating procedures (SOPs). Review and approve process, quality control, maintenance manuals, and batch/lot releases. Investigate deviations, failures, non-conformances, out-of-specification results, and customer complaints; implement corrective and preventive actions (CAPA). Ensure calibration and maintenance of all instruments and test equipment used for inspection and testing. Ensure compliance with statutory and regulatory standards such as ISO and other applicable guidelines. Oversee validation of processes, analytical methods, and equipment, and review validation reports. Approve analytical reports for finished products, ensuring conformity to standards and customer specifications. Maintain proper control over the use of product labels in line with statutory requirements. Ensure proper inspection and test status of all materials in accordance with laid-down procedures. Conduct internal audits for quality systems, monitor corrective actions, and ensure closure. Conduct training programs to enhance quality awareness among staff. Desired Candidate Profile: Proven experience in quality assurance/quality control in [insert industry, e.g., pharma, FMCG, etc.]. Strong knowledge of quality management systems, ISO standards, GMP/GLP compliance. Excellent problem-solving, analytical, and communication skills. Ability to lead internal audits and drive a culture of quality compliance.

Role & responsibilities 1) Engineering daily round and document verification in order to compliance. 2) Verification of Calibration planner, preventive maintenance planner to ensure activity done as per scheduled plan. 3) GPS clock time verification across the plant as per schedule, Alarm verification of equipment as per planner. 4) Audit trail verification of equipment (Drug product & Engineering area). 5) Review of memo in system and ensure closure in time with coordination to cross functional team with proper evaluation. 6) Preparation / review of Media fill protocol and report. 7) Preparation of process / cleaning validation protocol & report. 8) Review of cross functional documents (SOP, Validation protocol / report, Study protocol / report etc.) 9) Review and evaluation of QMS documents (Change control, Deviation, Incident etc. 10) Verification and review of Qualification/ Validation activities. 11) Co-ordinate with the cross functional departments as and when required. 12) Any other work allocated by Department 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

Sun Pharmaceutical Industries Ltd. Position: Senior Officer Quality Control Grade: G12B Location: API Dahej Location To perform In process, Intermediate, Process validation, Raw material, Packing material, Stability, Working standard and finished product chemical sample analysis with proper documentation. Registration off All stages sample in LIMS etc. Maintain of Inward register, instrument usage log books. Preparation and documentation of volumetric solution/regents. To ensure laboratory and instruments are clean. Ensure that GLP and safety during activity. Other activities instructed by Head QC/Designee from time to time. To ensure laboratory and instruments cleaning before start the analysis. Maintain traceability of Working / Reference / Pharmacopeia / Impurity Standards and laboratory reagents/Chemicals.

bmr review, Bpr review, sop preparation,

Job Overview To ensure effective quality assurance activities related to batch release, review of analytical data, batch records, QMS elements, and compliance with regulatory standards to support timely product release. Roles & Responsibilities: Batch Release Management Hands on analytical experience Review of QC Analytical Data including electronic data review Review of Batch Records including audit trail review Preparation and Review of APR Responsible for review of QC activities Initiation and review of QMS elements (Deviation/Change Control/OOS/OOT/CAPA) Dispatch and Line clearance Cleaning Validation Competencies Quick learner with excellent communication skills Punctual with proven track record of dedication & reliability A team player who is equally capable of working alone Fluent in both written and spoken English Knowledge /Experience in peptides Qualifications M.Sc. (Chemistry)/B. Pharm./ M.Pharm.

Role & responsibilities: Preferred candidate profile :

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.

Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund

Responsibilities Candidate must have Master degree in Organic chemistry with 3-8 years of experience in R&D / process development /scale up/ plant support. To plan and perform bench scale experiments and generate accurate and reproducible data. Coordination with ADL team for analytical support Process development, process optimization, process validation, determination of critical reaction parameters for existing as well as new process. Experience in handling of hazardous chemicals in the laboratory with safety precaution. Experience in Pilot and Plant support. Having knowledge of technology transfer from Lab to KG lab/pilot/plant level. To maintain proper documentation and housekeeping in the laboratory. Key Skills and competencies Good knowledge of Organic Chemistry and literature search Practical hand, positive and confident individual and good team player.

Responsibilities Candidate must have Master degree in Organic chemistry with 2-8 years of experience in R&D / process development /scale up/ plant support. To plan and perform bench scale experiments and generate accurate and reproducible data. Coordination with ADL team for analytical support Process development, process optimization, process validation, determination of critical reaction parameters for existing as well as new process. Experience in handling of hazardous chemicals in the laboratory with safety precaution. Experience in Pilot and Plant support. Having knowledge of technology transfer from Lab to KG lab/pilot/plant level. To maintain proper documentation and housekeeping in the laboratory. Key Skills and competencies Good knowledge of Organic Chemistry and literature search Practical hand, positive and confident individual and good team player.

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.

Formulation development of NCE projects, generic projects and line extension projects Preparation/review of literature summary and development report to the assigned product. Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches of assigned product. Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP. Representation in departmental audit Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same. Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition. Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required. Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS Communication with cross-functional team and client via mails, meetings and oral communication Responsibilities Qualifications -M. Pharm

Responsibilities: * Conduct BPR reviews, BMR reviews, process validation & cleaning validations. * Ensure compliance with industry standards during equipment & water validations. Accidental insurance Annual bonus Leave encashment Gratuity Provident fund

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

AM QC Chemist for Agro chemical Industry In Saykha,Bharuch, Gujarat Job Title: Executive/Sr Executive Department: QC Experience Required: 5 to 10 years Industry Manufacturing Production Quality Qualification M.Sc Key Skills Agro Chemical QC Chemist Quality Control Executive QC UPLC HPLC GC Agro GMP Compliance We are looking for a skilled Am QC Chemist to join our team in the Agro Chemical Industry. The ideal candidate will have 6-12 years of experience and be based in [location to be specified]. Roles and Responsibility Conduct quality control tests on agrochemical products to ensure they meet industry standards. Develop and implement quality control procedures to minimize defects and improve product quality. Collaborate with cross-functional teams to resolve quality-related issues and enhance overall product quality. Analyze data from quality control tests to identify trends and areas for improvement. Maintain accurate records of quality control activities, including test results and corrective actions. Ensure compliance with regulatory requirements and industry standards. Job Requirements Bachelor's degree in Chemistry or related field. Proven experience in quality control within the agrochemical industry. Strong knowledge of quality control principles, practices, and regulations. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Effective communication and interpersonal skills. Familiarity with industry-specific software and technologies.

Mould change & safety, HRS/MTC, hydraulic core, manpower handling, ERP data entry, computer skills, operator training, process validation, production planning, raw material handling (Nylon GF, PBT, ABS, PCABS), task execution, shop floor control." Perks and benefits Canteen Facilities

Roles and Responsibilities Conduct equipment qualification, validation, and vendor qualification activities according to established procedures. Perform process validation protocols, reports preparation, and CAPA implementation as required. Ensure compliance with regulatory requirements by maintaining accurate records of documentation and data analysis. Collaborate with cross-functional teams to identify areas for improvement in validation processes. Develop and execute test plans for new equipment installations or modifications.

QA Executive Qualification - B.Sc Chemistry/B.Pharm with 2 years of previous experience in medical devices/pharma. Tasks: Preparation, review & monitoring of Process Validation, machine validation, MOA, Specification, BMR, etc.Issuance, review & retention of all documents generated in organization

We are looking for a skilled QA Executive to join our team in the Agro Chemical Industry in Saykha, Bharuch, Gujarat. The ideal candidate will have 2-7 years of experience in quality assurance and control. Roles and Responsibility Develop and implement effective quality control processes to ensure high-quality products. Conduct regular audits to identify areas for improvement and implement corrective actions. Collaborate with cross-functional teams to resolve quality-related issues. Analyze data to identify trends and opportunities for quality improvement. Develop and maintain quality control documentation and records. Ensure compliance with industry regulations and standards. Job Requirements Bachelor's degree in any discipline. Proven experience in quality assurance and control. Strong analytical and problem-solving skills. Excellent communication and collaboration skills. Ability to work in a fast-paced environment and meet deadlines. Familiarity with industry-specific software and technologies.

QA Executive For Agro chemical Industry In Saykha,Bharuch, Gujarat Bharuch, Ahmedabad, Vadodara Job description Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Required Candidate profile Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility Experience 4 - 10 Years Industry IT Software - QA Testing Documentation Qualification M.Sc Key Skills Pharmaceutical Agro Chemical Quality Assurance Quality Assurance Analyst QA MSC Chemistry Chemical Agrochemical Quality Agreement GMP Guidelines