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:
* Plan and execute validation activities for fill and finish processes.
* Draft and review validation protocols and associated reports.
* Ensure production processes comply with regulatory standards (FDA, EMA, etc.).
* Collaborate with production, quality, and engineering teams to optimize processes.
* Identify and resolve issues related to process validation.
* Train and mentor teams on validation procedures.
Key Competencies:
* Expertise in fill and finish process validation.
* In-depth knowledge of regulatory standards and GMP.
* Ability to draft clear and precise validation protocols and reports.
* Project management and problem-solving skills.
* Excellent communication and collaboration skills.
* Ability to work independently and as part of a team.
* Proficiency with computer tools and validation software.
Desired Profile:
* Degree in pharmaceutical sciences, engineering, or a related field.
* Minimum 10 years of experience in the pharmaceutical sector, specializing in process validation.
* Proven experience in fill and finish process validation.
* Ability to manage multiple projects simultaneously and meet deadlines.
* Analytical mindset and attention to detail.
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