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VVF India Ltd Job Opening For MSc/ BSc/ M.Pharm/ B.Pharm - QA Department |
Urgently looking for QA Executive for Largest Chemical manufacturing plant at Taloja (Navi Mumbai)
Position : Executive QA
Job Responsibilities
- System/internal audits, vendor audits, vendor evaluation and support Laboratory-Quality activities.
- Performing all tasks required by QA such as making BMR's,BPR,OOS,OOT, SOP's, Change control system, Deviations, Market complaints, Annual review reports, Validations, Qualifications, Vendor Audits, internal-external audit compliance ,Trainings, Preparing other Documentation for example Site Master File & Validation Master Plan, QMS Implementation etc
- Risk Assessment, Cleaning Validation, failure modes and effects analysis (FMEA), HACCP
- SOP as per FDA & GMP Guidelines, Packing Material Development skill.
- Observing the units of goods produced for visible defects, performing various tests on the samples drawn, noting down observations, accepting and rejecting lots on the basis of samples checked, assisting in implementation of quality control programs, assisting in preparation of training manuals and quality guidelines.
- Strong knowledge of industry-wide accepted quality norms is essential.
- Initiation of change control for QA and review of change control from other functions.
- Review of Master batch manufacturing, packing records and laboratory control records.
- Preparation of QA related SOPs and review of draft SOPs from other functions.
- Review of equipment/system related qualification document.
- Responsible for audit readiness and support for timely retrieval of document during the audit process.
- Knowledge on 21 FR part 11 compliance requirement, REACH, ICH and FDA guidelines.
- Experience in the handling of QMS (laboratory incidents, deviations, OOS and OOT).
Preparation and review of responses to queries timely.
- Responsible for facing Regulatory Audits from customers and authorities from regulated markets and be able to effectively communicate with them in English.
- Performing other tasks assigned by the quality Head.
Qualifications and Skills
- Excellent technical writing in English and editorial review and oral communication skills absolutely required.
- Excellent problem solving and auditing skills are required.
- Must be able to communicate effectively with customers and third parties and diverse audiences at all levels of an organization.
- Should be M.Sc / B.Sc / M.Pharm / B Pharm with total experience 3 5 year in Pharmaceutical Industry
- Must have sound working knowledge various GMP and GLP standards, familiarity and exposure with internal audits, external GMP audits required.
- Working knowledge of computer applications, such as MS Word, MS Excel and MS Power point.
Interested candidates can share profiles at trupti.chandarana@vvfltd.com
Regards
Trupti
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