Job Details:
Purpose of the position:
1. 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.
2. 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.
3. To ensure robust deployment of all Quality System elements across all GXP functions at the plant.
General Responsibilities:
1. Ensure effective implementation of Good Laboratory Practices, Good Manufacturing Practices & Good Documentation Practices in the plant.
2. Carryout Sampling & Testing of Raw & Packaging Materials, Intermediates, Bulk & Finished Products, as per the validated analytical test methods enabling timely & accurate disposition decisions.
3. Carryout in-process quality assurance checks during manufacturing of various products, to confirm adherence to validated processes.
4. Review & approval of Manufacturing Batch Records, Test reports & other GXP documents, enabling batch releases for dispatch to market.
5. Should have experience of handling instruments like HPLC, UV, FTIR and other common laboratory instruments.
6. Management of stability chambers and performing Stability studies and trending the data.
Qualifications
Qualification:
1. Education: Master’s degree in Pharmacy or Analytical Chemistry from a reputed university.
2. Sound knowledge of GMP, GLP and Regulatory Compliance.
3. Experience: Around 1-2 years in the Quality Assurance/Control function of a Pharmaceutical/Healthcare/FMCG Company.
4. Should be willing to work in shifts (A, B & C), 24x7 with staggered weekly off.
5. Good communication & interpersonal skills, flair for quality, team player, quick learner.
6. Should have a good work and time management skills.
Reporting Relationships:
1. Reports to: Asst. Manager - Quality & Compliance
2. Direct Report: None
Primary Location:Asia Pacific-India-Maharashtra-Greater Mumbai...
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