
MS&T Validation Specialist
14 hours ago
Job Summary
We are seeking a highly skilled Validation and Life Cycle Management Expert to join our team. The ideal candidate will have a strong background in organic chemistry and experience with process and cleaning validations.
Responsibilities:- Prepare and update Risk Assessments and Validation related documentation, ensuring compliance with cGMP requirements.
- Support Technical Transfers and Life Cycle Management activities.
- Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
- Provide technical expertise and facilitate the creation of quality risk assessments.
- Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams.
- Minimum 5 years of experience in MS&T (Process and Cleaning and Transport Validations) or in the manufacturing of pharmaceutical Drug substance in Sterile/Large Molecules platform/facility.
- Excellent project management skills and ability to work in a cross-functional environment.
- Expertise in reviewing and writing technical reports.
- Strong communication and interpersonal skills.
- Quality / Accuracy / Right First Time.
- Timeliness.
- Deviations / Escalations.
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