Quality Assurance Manager

1 month ago

Surat, India R.N. Laboratories Private Limited Full time

JOB RESPONSIBILITIES:

  • Follow the standard operating procedure (SOP) relevant to the analysis of the products.
  • Review of verification & method validation protocols for analytical methods inclusive of Assay, related substances and residual solvent.
  • Responsible to resolve any regulatory queries related to analytical methods and related impurities.
  • To receive the documents viz, Specification, SOP, Formats and test protocols etc. as required for the system.
  • Manage the compliance to each deficiency found in the quality control system.
  • Establishing specification and method of analysis of RM, PM, & FP.
  • Ensure completeness of documentation and validation of process & analytical methods as per cGMP requirements.
  • Involved in the Analytical Method development and Validation Activities.
  • Authority to approve or disapprove any material viz., RM/PM/INT/FP or any incoming material subjected to quality matters, on consultation with Head Quality if require.
  • Review of In-process testing report, Raw material Testing Report, Packing material testing report and FP testing report.
  • Calibration of analytical instruments as per calibration planner. Record / format fill up for calibration performed. Status label preparation. Review of Calibration record.
  • Monitoring of Laboratory chemicals. Raise Purchase requisition for indent of lab chemicals and consumables including stationary.
  • Receipt of samples from Unit 1 and Analysis of samples received from Unit 2 for HPLC, GC. IR and Polarimeter. Report preparation and review of analysis.
  • Review of stability testing record and protocol.
  • Preparation / revision of documents as per requirement of QA for submitting compliance to customer or regulatory audit.
  • Ensure QC internal and external compliance investigation (CAPA, OOS, OOT, Deviation, Incidence etc.)
  • Review of APQR and coordinate in APQR preparation with QA.
  • Conduct internal as per defined schedule by QA.
  • Conduct outside laboratory audit as and when required.
  • Ensure all analysis release on time with proper compliance.
  • Taking suitable decision in co-ordination with next superior level in case of absence of QA/QC/RA head.
  • Perform the method validation activity as per approved method validation protocol.
  • Preparation of Analytical method validation report after completion of the activity.


Education Qualification


M. Sc / B. Sc in Chemistry / Organic Chemistry


Experience

20 + Years of experience in API


Audit Experience

Must have handled USFDA, WHO, ENVISA, GMP, etc

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