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Senior Officer Quality Assurance

Mumbai, MH
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  • Retail & Wholesale
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Job Details

Purpose of the positionTo ensure compliance to the requirements of Good Manufacturing Practices (Schedule M of D&C Act) in all 3 manufacturing workshops (Band-Aid, Baby Powder & Sanitary Napkins) of the plant.To ensure robust deployment of all Quality System elements across all GXP functions at the plant.To ensure compliance to the requirements of Good Laboratory Practices (Schedule L-I of D&C Act) in the Quality Control Laboratory, enabling timely & accurate disposition for incoming materials, intermediates, bulk & finished products manufactured at the plant. General ResponsibilitiesEnsure effective implementation of Good Laboratory Practices, Good Manufacturing Practices & Good Documentation Practices in the plant.Carryout Sampling & Testing of Raw & Packaging Materials, Intermediates, Bulk & Finished Products, as per the validated analytical test methods enabling timely & accurate disposition decisions.Carryout in-process quality assurance checks during manufacturing of various products, to confirm adherence to validated processes.Review & approval of Manufacturing Batch Records, Test reports & other GXP documents, enabling batch releases for dispatch to market.Conduct investigations related to Non-conformances, Deviations & Market Complaints and build robust CAPA to avoid recurrences.Conduct Risk Assessments on changes in Men, Materials, Machines, Methods and drive compliance.Ensure proper execution & documentation of the Qualification (DQ, IQ, OQ & PQ) for the Laboratory and Manufacturing Equipment.Conduct GXP trainings and drive effectiveness.QualificationsQualificationEducation Masters degree in Pharmacy or Analytical Chemistry from a reputed university.Sound knowledge of GMP, GLP and Regulatory Compliance.Experience Around 5 years in the Quality Assurance/Control function of a Pharmaceutical/Healthcare/FMCG Company.Should be willing to work in shifts (A, B & C), 24x7 with staggered weekly off. Good communication & interpersonal skills, flair for quality, team player, quick learner
Degree: M.Pharm. (Pharmacy)

Additional Degree: B.Pharm. (Pharmacy)

Experience: 3-6


Quality Assurance | Quality Control | Quality Inspection | Total Quality Management
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