Job Description
Quality Assurance Specialist responsible for managing Quality Assurance activities, ensuring compliance with Good Manufacturing Practice (GMP) regulations, and providing support to all departments to meet business, quality, and compliance goals.
This role involves managing Quality Assurance activities, ensuring compliance with Good Manufacturing Practice (GMP) regulations, and providing support to all departments to meet business, quality, and compliance goals. Key responsibilities include:
- Managing batch records, material release, and change control systems
- Coordinating event management, supplier qualification, and validation activities
- Reviewing and approving SOPs, work instructions, and forms
- Participating in new product introductions and performing GMP audits
- Ensuring compliance with FDA and EMEA regulatory requirements
Key skills and competencies required for this role include:
- Excellent interpersonal and communication skills
- Ability to operate as part of a team
- Customer focus and innovative thinking
- Attention to detail and good problem-solving skills
- Results-driven and adaptable
Qualifications and experience required for this role include:
- Bachelor's degree in a scientific or technical discipline
- Minimum 3-5 years of experience in quality, validation, or compliance roles in the biological and/or pharmaceutical industry
- Knowledge of FDA and EMEA regulatory requirements
PE Global is a leading recruitment agency, and we are committed to finding the best talent for our clients. We will review all applications and provide feedback to candidates. If you are interested in this role, please submit your CV and a brief cover letter outlining your qualifications and experience.