We are working with a leading pharmaceutical company dedicated to the development, manufacturing, and commercialization of small molecule therapeutics. Their mission is to improve patient outcomes through innovative and high-quality products.
We are seeking a detail-oriented Quality Assurance Specialist to join the client on a 12 month contract, playing a critical role in ensuring that the client's small molecule products meet all regulatory and quality standards. This position involves working closely with various departments to maintain compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
Key Responsibilities:
- Review and approve documentation related to the manufacturing, testing, and release of small molecule products, including batch records, SOPs, and validation protocols.
- Ensure compliance with GMP, FDA, EMA, and other regulatory requirements, conducting internal audits and participate in external audits.
- Collaborate with the Quality Control team to ensure that all testing procedures are followed and that results meet quality standards.
- Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs) to address issues and prevent recurrence.
- Provide training to staff on quality-related topics and ensure that everyone is aware of and adheres to quality standards.
- Participate in continuous improvement initiatives to enhance quality processes and systems, identifying areas for improvement and implementing changes as needed.
- Conduct risk assessments and develop mitigation strategies to ensure product quality and patient safety.
Qualifications:
- Bachelor's degree in Chemistry, Biology, Pharmacy, or a related field.
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry, with a focus on small molecule products.
- Strong understanding of GMP, FDA, EMA, and other regulatory requirements.
- Strong familiarity with quality management systems.
Contract:
- Start date: ASAP
- 12 month contract
- 40 hours per week
- Hybrid (2 days on site)
- W2 only
