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Position: Assitant Manager – Quality Assurance – Third Party Manufacturing

Location: 147, Greams Road, Chennai, Tamil Nadu, India

Job Description:

TPM Products at contract manufacturing sites:

  • Control Sample: Control sample of each product to be reviewed for physical parameters twice in a year and timely escalate the product issues and track for the closure of action plans.
  • Stability: Minimum one stability station analysis to be witnessed at the site annually along with a physical description. Stability data of each product for all stations to be reviewed for compliance.
  • The product manufacturing process of validation batches to be witnessed with cross verification of in-process checks and observations to be done for any stage in compliance to approved procedures for validation batches or minimum one batch in a month.
  • Finished product analysis for critical chemical (dissolution, RS & Assay) and physical quality attributes to be witnessed monthly one batch / as per plan for analytical compliance & GLP requirements at the site.

  • Water & environment trend, MLT procedure & data of product/material analysis to be witnessed and trends to be reviewed quarterly or as per site schedule.
  • Raw materials & primary packing material of products to be reviewed with approved specification and pharmacopeial compliance once in six months for all products & ensure compliance if any necessary changes required to be done.
  • APQR: Review of trends of critical quality attributes for any significant shift and ensure implementation of recommendations to improve the trend for next year.
  • Technology transfer: Checklist of products for initiation of technology transfer of products to be verified for compliance. Process validation batches to be witnessed & reviewed for compliance with the approved protocol (process validation, hold time study & stability study). Deviation to be addressed for process changes approval.
  • FLQR: Review of documents and samples to be done for compliance with FLQR procedure and release of the batch.

Qualification: B.Sc/M.Sc, B.Pharma/M.Pharma

Experience: 10-15 Years relevanT QA Experience at internal sites / third party manufacturers.

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