QC MANAGER

Job Description:

Preparation of Certificate of Pharmaceutical Product.

• Expertise in liaising, coordinating inspections with regulatory agencies (FDA ISO    9000)
• Knowledge of Microsoft Office, Microsoft Excel, ERP etc.
• Goal Oriented and Results Driven Team Leader.
• Expertise in writing, reviewing & approving lab procedures / documentations, Out off   Specification                     reports, batch records, protocols, etc.

• Review of QC related specification, STP and analytical test data sheet (FP and intermediates).
• Review of QMS documents like As OOS, OOT ,Disregard /Incident and deviation within given timeframe .
• To carry out Investigation for Out of trend and Out of Specifications.
• Review of qualification, calibration and working standard documents of Quality Control department.
• Data integrity and compliance with c GMP.
• Completeness with ALCOA.
• Looking after Calibration of Instruments and status labels.
• Working standards ,reference standards and Impurity standard managment as  per GLP
• Review of Usage Log book / Entry register and status labels are complied as per SOP
• Procurement of various consumable items required for quality control.
• GDP maintain as per USFDA and as per company policy.
• Review of audits trials of various instruments like as HPLC,GC, UV , IR .
• Looking after general aministration., in laboratoty.

Desired Profile / Criteria / Skills :

Candidates must be B.sc/M.sc / B.Pharma/ M.Pharma with 15-16 Year Experience As a QC Manager