Description
Role-Quality and Compliance Analyst (Pharma exp.)
Location- Södertälje, Sweden
Duration- 6+months
Skills:
- Must speak Swedish and English
- Minimum 5 Years quality assurance/pharmaceutical experience
- Pharmaceutical operations knowledge
- GMP and QA system background relating to computer systems.
- GMP regulations including EU, US-FDA
- Good Automated Manufacturing Practice - GAMP 5.0
- Assessment of computer validation approaches and electronic records
Excellent working knowledge of:
- EudraLex Annex 11, 15
- US - CFR's 210 & 211 GMP
- US - CFR's Part 11 Ruling
- US - CFR Part 11 Revised Scope
- GAMP 5.0 All chapters
- Risk Based Approach for Computer Systems
- Fundamental understanding of Sarbanes Oxley Data Security 404
Roles & Responsibility:
- Assessment of computer system regulatory risks against the requirements of GMP regulations
- Perform and document risk assessment and gap analysis
- Establish validation planning including approach, deliverables, team responsibilities
- Create validation and qualification life cycle deliverables
- Review and approve supplier documentation
- Provide clear communication to project teams on validation approach and deliverables
- Provide regular project reporting
- Develop and support client operational procedures for computer system validation
- Develop and support client training for computer systems validation
- Ensuring traceability across validation deliverables
- Ensuring good document management practices are followed