Quality Assurance Officer

2 weeks ago

Gujarat, India SV Placement Full time

4 - 5 years
- Sarigam, Gujarat
- 4-7 Lacs P.A.
- 1 hour agoAPPLY

We are seeking a highly skilled and motivated Quality Assurance Officer to join our team focused on API manufacturing. The Quality Assurance Officer will play a critical role in ensuring compliance with regulatory requirements, maintaining quality standards, and driving continuous improvement initiatives within our API manufacturing operations.

**Role & Responsibilities**:

- Ensure compliance with regulatory standards (eg, FDA, EMA, ICH) and company policies and procedures related to API manufacturing
- Implement and maintain robust quality systems, including document control, deviation management, change control, and CAPA (Corrective and Preventive Actions) programs
- Conduct thorough review and approval of batch records, ensuring accuracy, completeness, and adherence to established procedures
- Identify and assess quality risks associated with API manufacturing processes and implement risk mitigation strategies as needed
- Collaborate with procurement and supplier management teams to assess and ensure the quality of raw materials, packaging materials, and contracted services
- Experience in quality assurance or quality control roles within the pharmaceutical industry, with specific experience in API manufacturing prefer
- Opening- 1- Employment Type- Full Time, Permanent- Industry Type- API Industry- Functional Area- Quality Assurance- Education- B.Sc, M.Sc in Chemistry- Key Skills- API manufacturing
- GMP
- Regulatory compliance
- Quality systems
- CAPA

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