Quality Assurance & Compliance Lead

We are seeking a highly experienced and dynamic individual to join our team as the Quality Assurance & Compliance Lead in our clients Pharmaceutical and Bio-Pharmaceutical Industry. The successful candidate will play a pivotal role in ensuring the production of high-quality, safe, and effective products that comply with global regulatory standards. The primary focus will be on microbiological, sterility assurance, and contamination control strategies.
Key Responsibilities:
- Provide strategic direction to functional areas for maintaining compliance with global regulatory expectations.
- Ensure adherence to Sterility assurance, and Contamination control strategies.
- Lead qualification and validation activities for process and laboratory equipment and facilities.
- Play a key role in professional planning and implementation of qualification and validation activities throughout the system life cycle.
- Ensure project compliance with CSV Policies and external regulations (FDA CFR Part 1, 21 CFR Part 820.70, EudraLex Annex 11, etc.).
- Review and approve Global CSV documents related to system retirement or separation due to the divesting of a manufacturing site.
Qualifications:
1. Experience: Minimum of 12-15 years in Pharmaceutical and Bio-Pharmaceutical Industries.
2. Education: Bachelor's or advanced degree in a relevant field.
3. Regulatory Knowledge: In-depth understanding of FDA CFR Part 1, 21 CFR Part 820.70, EudraLex Annex 11, and other relevant regulations.
Skills and Competencies:
1. Strong leadership and team management skills.
2. Excellent communication and interpersonal skills.
3. Thorough understanding of microbiological, sterility assurance, and contamination control strategies.
4. Proven experience in CQV activities and compliance management.
If you are a seasoned professional looking to contribute to the success of a leading pharmaceutical organization, we invite you to apply for this exciting opportunity. Join us in our commitment to delivering exceptional quality and compliance in the pharmaceutical and bio-pharmaceutical sector.