We are seeking an experienced Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance within the pharmaceutical industry, with a focus on GMP compliance. The QA Specialist will be responsible for ensuring that all products are manufactured, tested, and released in accordance with established specifications, standards, and procedures.
- Ensure compliance with current Good Manufacturing Practices (cGMP) regulations and guidelines.
- Review and approve batch records, validation protocols and reports, and other quality-related documentation.
- Perform internal audits and ensure that corrective and preventive actions are implemented in a timely manner.
- Provide guidance and support to manufacturing and laboratory personnel on quality-related issues.
- Investigate deviations, out-of-specification results, and other quality-related issues and ensure that appropriate corrective and preventive actions are taken.
- Maintain the company's quality system and ensure that all quality-related documentation is accurate, complete, and up-to-date.
- Participate in the development, implementation, and maintenance of quality-related procedures and policies.
- Provide support during regulatory inspections and customer audits.
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent combination of education and experience.
- Minimum of 3-5 years of experience in quality assurance in the pharmaceutical industry.
- Strong knowledge of current Good Manufacturing Practices (cGMP) regulations and guidelines.
- Experience with reviewing and approving batch records, validation protocols and reports, and other quality-related documentation.
- Experience with conducting internal audits and investigating deviations and out-of-specification results.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
If you are a highly motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity. We offer a competitive salary, comprehensive benefits package, and the opportunity to work with a talented and dedicated team of professionals.