AddressJob Summary:
The In-Process Quality Assurance Executive will be responsible for ensuring that all products are manufactured and packaged in accordance with cGMP and other regulatory standards. The position will work closely with production teams to monitor and verify the quality of products throughout the manufacturing process.
Key Responsibilities:
- Ensure quality is maintained from warehouse, to production, and packing.
- Ensure compliance with cGMP and other regulatory requirements for the manufacturing and packaging of products.
- Work closely with production teams to identify and resolve quality issues in real-time.
- Participate in investigations of deviations and non-conformances, and provide support for root cause analysis and corrective and preventive actions (CAPAs).
- Maintain accurate and complete documentation of all quality-related activities.
- Participate in internal and external audits and inspections, and provide support for the preparation of responses to findings and observations.
- Provide guidance and training to production personnel on quality-related topics.
- Participate in the development and review of quality-related procedures and policies.
- Stay up-to-date with the latest regulatory requirements and industry best practices for in-process quality assurance.
Qualifications:
- Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or related field.
- At least 1 year of experience in in-process quality assurance in the pharmaceutical industry.
- Strong knowledge of cGMP and other regulatory standards for in-process quality assurance.
- Excellent problem-solving, communication, and interpersonal skills.
- Ability to work independently and in a team environment.
- Experience in participating in investigations of deviations and non-conformances, and providing support for root cause analysis and CAPAs.
- Strong analytical and documentation skills.
- Experience in participating in internal and external audits and inspections.
