Officer/Executive - QA
- Vadodara, Gujarat
- Permanent
- Full-time
- Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process.
- Ensure all operations comply with GMP guidelines and internal quality standards.
- Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements.
- Participate in the review and approval of finished product batch records and assist in product release processes.
- Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner.
- Support the quality control laboratory in ensuring that all testing is performed in accordance with regulatory guidelines and company procedures.
- Prepare, review, and approve validation & Callibration documentation such as protocols, reports, and qualification documents (IQ/OQ/PQ) for equipment, systems, and processes.
- Assist in the execution of validation activities for equipment, systems, utilities, and processes to ensure compliance with GMP and other regulatory requirements.
- Experience of GMP & FDA documentation.
- Must be excellent in written and spoken English; net savvy and adept at computer skills.
- Logical thinking.
- Organizing.
- Good in communication.