Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices & Diagnostics, which are independently managed and report into their respective Global business segments. J&J Medical India (JJMI) is the market leader in the Medical Company Devices & Diagnostics Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Orthopaedics, Infection Prevention, Wound Management, Women’s health, minimally invasive surgery, Circulatory disease management.
Post : Officer- Quality Assurance
Job Description
Role Overview: To ensure compliance to the requirements of Good Manufacturing Practices (Schedule M of D&C Act) during manufacturing of the Cosmetics product in 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.
Role Overview: To ensure compliance to the requirements of Good Manufacturing Practices (Schedule M of D&C Act) during manufacturing of the Cosmetics product in 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.
Illustrative 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 finished product releases in SAP 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.
• To participate in deployment of Enterprise Quality Policy Standards, Technical standards, WWSPs, QSPs, local SOPs applicable to the site. Conduct GXP trainings and drive effectiveness.
• Active participation in plant Gemba round and ensure timely closure of the observations.
• Stability Management for the site, which includes preparation of MPS protocol, Stability reports, Stability Planner & Management of Stability Chambers etc.
• 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 finished product releases in SAP 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.
• To participate in deployment of Enterprise Quality Policy Standards, Technical standards, WWSPs, QSPs, local SOPs applicable to the site. Conduct GXP trainings and drive effectiveness.
• Active participation in plant Gemba round and ensure timely closure of the observations.
• Stability Management for the site, which includes preparation of MPS protocol, Stability reports, Stability Planner & Management of Stability Chambers etc.
Candidate Profile
• Education: Master’s degree in Pharmacy or Chemistry from a reputed university.
• Sound knowledge of GMP, GLP and Regulatory Compliance.
• A minimum of 4+ and up to 6 years of experience in 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.
• Candidates with Himachal Bonafide will be preferred.
• Education: Master’s degree in Pharmacy or Chemistry from a reputed university.
• Sound knowledge of GMP, GLP and Regulatory Compliance.
• A minimum of 4+ and up to 6 years of experience in 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.
• Candidates with Himachal Bonafide will be preferred.
Additional Information
Experience : 4+ years
Qualification : M.Sc./ M.Pharm
Location : Himachal Pradesh
Industry Type : Pharma
Functional Area : QA
End Date : 30th December, 2018
Experience : 4+ years
Qualification : M.Sc./ M.Pharm
Location : Himachal Pradesh
Industry Type : Pharma
Functional Area : QA
End Date : 30th December, 2018
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