API Quality Assurance Lead
2 days ago
We are seeking an experienced API Quality Assurance Manager to join our team at Jay FineChem Private Limited. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality in the manufacture of APIs (Active Pharmaceutical Ingredients).
The ideal candidate will have a minimum of 15-20 years of experience in the API industry and a strong background in quality assurance. A Bachelor's or Master's degree in Pharmacy (B. Pharm/M. Pharm) or Organic/Analytical Chemistry (M. Sc) is required.
Our company offers a competitive salary of $150,000 - $200,000 per annum, commensurate with experience, as well as benefits such as health insurance, retirement plan, and paid time off.
Job Description:
- Conduct audits in plants to implement cGMP systems and ensure compliance with regulatory requirements.
- Train QA personnel on quality control operations and its compliance, computerized system validations, and analytical method verifications.
- Perform qualification of various analytical instruments in the laboratory and review data backup and restoration.
- Review elemental impurity risk assessment and Nitrosamine impurity risk assessment, and approve vendor qualification documents.
- Organize and execute internal audits at all plants and corporate departments as per the annual planner.
- Ensure compliance with cGMP, cGLP requirements, and good documentation practices.
Key Responsibilities:
- Develop and implement quality control strategies to ensure compliance with regulatory requirements.
- Conduct regular audits and inspections to identify areas for improvement.
- Collaborate with cross-functional teams to resolve quality-related issues.
- Develop and maintain quality control procedures and protocols.
- Provide training and guidance to QA personnel on quality control operations and its compliance.
Requirements:
- Minimum 15-20 years of experience in the API industry.
- Bachelor's or Master's degree in Pharmacy (B. Pharm/M. Pharm) or Organic/Analytical Chemistry (M. Sc).
- Strong knowledge of cGMP, cGLP, and regulatory requirements.
- Excellent communication and leadership skills.
Benefits:
- Competitive salary: $150,000 - $200,000 per annum.
- Health insurance.
- Retirement plan.
- Paid time off.
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