Head of Quality Control (QC)
Posted on 12.9.2014
The main task of the Head of QC is to manage, plan and direct Quality Control and Microbiology laboratories to ensure lab testing and provide the highest quality analytical support for manufacturing, while ensuring compliance with protocols, GMP and safety regulations. The head must also serve as a QC consultant on analytical project teams and product operational teams and provide leadership, management, evaluation and training to all laboratory employees.
- Serve as QC lead on analytical project teams and product operational teams
- Provide leadership, management, evaluation and training to all laboratory employees
- Direct the work activities of the raw material/finished product and microbiology work groups to ensure that testing is executed in a timely and compliant manner
- Review and approve Certificate of Analysis, Certificate of Test, and stability studies
- Demonstrate technical proficiency in analytical methodology and adherence to GMP and ICH compliance
- Execute and approve all laboratory investigations
- Review and investigate all laboratory data outside of trend
- Review and approve protocols and reports such as Method Validation, Method Transfer, Process Validation and Stability
- Ensure all vendors have been qualified and adhere to vendor qualification standards with the aim of optimal utilization of the reduced testing procedure
- Establish and implement a KPI structure to ensure optimal test/cost ratio
Required Candidate profileGood Exposure With USFDA, EDQM, WHO and other regulatory audits.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role:Analytical Chemistry Associate/Scientist
Desired Candidate Profile
Doctorate:Doctorate Not Required
Biophore India Pharmaceuticals Pvt. Ltd.
Biophore is dedicated to consistently deliver complex & niche pharmaceutical products that exceed customer expectations and provide a rewarding work environment.
Recruiter Name:Seshukumar Ainala
Contact Company:Biophore India Pharmaceuticals Pvt. Ltd.