Quality Assurance - Aylesbury, United Kingdom - Sugama Technologies Ltd
3 weeks ago
Description
Job Description:
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:
Experience:
Minimum of 12-15 years in Pharmaceutical and Bio-Pharmaceutical Industries.
Education:
Bachelor's or advanced degree in a relevant field.
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:
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Thorough understanding of microbiological, sterility assurance, and contamination control strategies.
- Proven experience in CQV activities and compliance management.
Salary:
£42,000.00-£47,000.00 per year
Benefits:
- Employee mentoring programme
Schedule:
- Monday to Friday
Work Location:
In person
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