QC Manager
Job Description:
A "QC Manager - Sterile Formulation" job description entails overseeing all quality control operations within a sterile injectable drug manufacturing facility, ensuring that all products meet stringent regulatory standards by managing testing procedures for raw materials, in-process samples, and finished products, while maintaining compliance with cGMP guidelines and conducting thorough investigations for any quality deviations, all while leading a team of quality control analysts and ensuring their competency through training and development.
Quality Assurance Oversight:
- Manage all aspects of the QC laboratory, including sample analysis, data review, and release of raw materials, in-process materials, and finished products.
- Ensure compliance with cGMP regulations, USP/EP/JP pharmacopeia standards, and internal quality procedures.
- Conduct thorough investigations for Out-of-Specification (OOS) and Out-of-Trend (OOT) results, implementing corrective and preventative actions.
- Review and approve all QC documentation, including Standard Operating Procedures (SOPs), test protocols, and batch records.
Key Skills :
Company Profile
Company is a fast growing integrated pharmaceutical company which commenced its commercial production in 1991 and has increased in both size and stature to become one of the country’s largest producers of the Sterile API’s (Active Pharmaceutical Ingredients). Besides being the first company in India to produce Ampicillin Sodium Sterile, Company also pioneered the manufacturing of Sterile Anti-Ulcer drugs namely Omeprazole Sodium Sterile and Pantaprazole Sodium Sterile for which it has won worldwide acceptance.
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