:
1. Provide support on Validation related issues and site systems/equipment, supporting audits and inspections with respect to validation/qualification queries
2. To lead, coordinate, perform author, and support validation/qualifications, reviews and change control activities including equipment, facilities, systems, cleaning, distribution and CSV. Ensure the schedule is maintained, reports written on time according to the site master plan, and related documents kept current.
3. To champion validation activities and training material and carry out training in validation/qualification.
4. To agree scope of validation/qualification activities in line with company and regulatory requirements, and support audits and inspection with respect to validation/qualification activities.
5. Author/approve SOPs related to validation/revalidation activities
6. Represent QA validation in multi-functional meetings/projects as required
7. Work closely with engineering perform Site Acceptance Testing (SAT), IQ, OQ and PQ activities and protocols.
8. Conduct root cause analysis and deviation resolution for validation exceptions
9. To support related activities within validation and compliance as required by the validation manager.
10. Conducts all activities in a safe and efficient manner
11. Actively participate in departmental improvement programmes.
Minimum Requirements/Qualifications:
12. Relevant Pharmaceutical/GMP Proven experience
13. Previous experience in validation/CSV role
14. Knowledge of GMP legislation
15. Experience in dealing with Local and Regulatory Authorities
16. Excellent presentational & motivational skills
17. Ability to establish effective working relationships and effective communicator