Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.
Post :Senior Officer – Quality Assurance
Role Overview
1. To 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.
2. To ensure robust deployment of all Quality System elements across all GXP functions at the plant.
3. 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.
Job Responsibilities
- Ensure 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.
Candidate Profile :
- Education: Master’s 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.
Reporting Relationships:
Reports to: Asst. Manager - Quality & Compliance
Direct Report: None
Additional Information:
Qualification : M.Pharm
Location: Mumbai, Maharashtra
Job Function: QA
Requisition ID: 1600120501W
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