QC Manager

Quality & Compliance Responsibilities:

• To follow the Quality Policy.
• To follow the GMP and GDP Guidelines.
• To follow the Data Integrity Policy.
• To follow the Health and Personal Hygiene Policy.
• To follow the discipline and code of conduct of the company.
• To follow the GLP Guidelines& maintain discipline in Department.

Technical Responsibilities:

• Functioning of overall Quality Control Department.
• Identification, procurements and managing of resources for Quality Control Department.
• Approval/Rejection of Finish Product/Raw Material/Packing material/Water analysis, process validation samples and Stability testing in Quality Control Department. based on testing results.
• Handling of Overall QMS activity in Quality Control Department like, - Change Control, Deviation, Laboratory incidence, CAPA etc.
• Investigation of OOS/OOT results in Quality Control Department & closure of related activity.
• Monitoring of Qualification of laboratory instrument/equipment (i.e.IQ/OQ/PQ).
• Monitoring/Maintaining calibration activity of laboratory instrument/equipment.
• Approval of various Quality Control Documents like,-Completed analytical reports, Calibration Reports, Analyst Qualification documents, analyst job description, protocols etc.
• Preparation of GMP documents like, SOPs, Product specification, Standard Test Procedure, Protocols, GTP, Analytical worksheet etc.
• Method Validation/Verification/Method transfer activity.
• Review of all the Log books, QC Records, Qualification documents & other GMP Documents.
• Monitoring analyst qualification activity & certification in QC & Micro Department.
• Guide & support to all the Quality Control team for completion of routine activity in the Department.
• Support to cross functional team for completion of all the goals & vision of company.
• To maintain discipline in Quality Control Department
• Compliance of Overall Quality Control Department activity