Quality Control Manager

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 QualificationM. Sc / B. Sc in Chemistry / Organic ChemistryExperience20 + Years of experience in APIAudit ExperienceMust have handled USFDA, WHO, ENVISA, GMP, etc PRB