We are seeking an experienced consultant for the validation of fill & finish processes for one of our client. The ideal candidate will have a strong background in the pharmaceutical industry and will ensure that production processes comply with regulatory standards and Good Manufacturing Practices (GMP).
Responsibilities:
1. Plan and execute validation activities for fill and finish processes.
2. Draft and review validation protocols and associated reports.
3. Ensure production processes comply with regulatory standards (FDA, EMA, etc.).
4. Collaborate with production, quality, and engineering teams to optimize processes.
5. Identify and resolve issues related to process validation.
6. Train and mentor teams on validation procedures.
7. Expertise in fill and finish process validation.
8. In-depth knowledge of regulatory standards and GMP.
9. Ability to draft clear and precise validation protocols and reports.
10. Project management and problem-solving skills.
11. Excellent communication and collaboration skills.
12. Ability to work independently and as part of a team.
13. Proficiency with computer tools and validation software.
Desired Profile:
1. Degree in pharmaceutical sciences, engineering, or a related field.
2. Minimum 10 years of experience in the pharmaceutical sector, specializing in process validation.
3. Proven experience in fill and finish process validation.
4. Ability to manage multiple projects simultaneously and meet deadlines.
5. Analytical mindset and attention to detail.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Consulting
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr