Validation Expert – MS&T
· The subject matter expert in validation processes in ensuring products/processes meet regulatory requirements and quality standards
· Support all operational aspects of MS&T department including technology transfer, process monitoring/support, change control and deviation closure. Y
Responsibilities:
· Develop, implement and manage the site process validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
· Collaborate with cross functional teams to define the interfaces to equipment qualification / utilities qualification, system qualification and analytical method validation.
· Establish and maintain the Validation Master Plan for process and cleaning validation. Ensure that all manufacturing and cleaning processes are validated, overview on state of validation at site is maintained.
· Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation. Provide technical expertise for pre-validation / validation strategy.
· Author or reviewer for routine validation protocols and reports, reviews Master Batch Records (MBRs), associated change controls and supports the execution at the shop floor.
· Develop the strategy for ongoing process and cleaning verification and annual monitoring strategy that ensures all critical process parameters and quality attributes are monitored or analysed, and actions are defined and taken in case of trends or deviations. Reviews risk assessments for CPV.
· Lead and drive investigation for validation related matters and implement corrective and preventive actions.
· Support the operations team to ensure that all batches are produced safely, on time, and in compliance with manufacturing specifications and quality requirements.
· Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards.
· Initiate, drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety and efficiency.
Requirements:
· BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemistry, or equivalent scientific / engineering degree.
· Proven relevant experience in validation role in manufacturing/MS&T department within bio/pharmaceutical industry
· Good knowledge in vaccines process development/manufacturing/fill and finish
· Knowledge of the current regulatory requirement and good understanding for guidance document for instance FDA/ICH/EMEA/cGMP
· Hands on experience in project management, validation activities, GMP expertise and good understanding of working in GMP environment.
· Ability to adapt to changing priorities effectively and work at the start-up environment.
· Excellent communication skills and ability to effectively collaborate in dynamic, cross functional matrix environment.
Reg No.: R2090579
EA License No.: 02C3423
Recruitment Consultant
Manpower Singapore
