The Company
A global pharmaceutical and medical device organisation known for its commitment to quality, compliance, and innovation. The company operates under strict GMP regulations and supports advanced manufacturing and validation processes.
About the Role
This role provides QA Validation Specialist oversight for equipment validation, packaging qualification, and PASX master data management. The Sr. Associate ensures compliance with corporate, site, and regulatory standards while supporting change control and deviation management processes.
Responsibilities
- Review and approve equipment validation documentation
- Provide QA support for testing strategies and investigations
- Oversee and approve PASX master data entries
- Guide validation strategies in collaboration with PD, M&E, and IS teams
- Approve equipment changes and parameter updates
- Manage device-related responsibilities in alignment with GMP
- Perform final QA review of technical change controls
- Act as QA SME for technical changes and deviation records
Requirements
- MBO or Bachelor’s degree in Life Sciences or Process Technology
- Minimum 3 years of experience in pharmaceutical or medical device industry
- Strong knowledge of GMP, equipment and automation validation
- Familiarity with computer compliance (Annex 11, Part 11)
- Experience with manufacturing and quality analytical processes
- Fluent in English
- Preferred: Experience with deviations and change control
Other Information
Cross-functional collaboration with PD, M&E, IS, and other QA teams
56562
Similar jobs
About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.