Validation Manager
Manage contractor company for develop and execute equipment qualification protocols for facilities/utilities and supporting these operations.
· Develop and execute cleaning validation/verification protocols for all commercial and R&D manufacturing, processing, and food equipment.
RESPONSIBILITIES
· Develop and execute cleaning validation/verification protocols for all commercial and R&D manufacturing, processing, and food equipment.
·Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
· Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis and equipment logs.
· Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
· Draw conclusions from data, observations, deviation/exception and investigation as to whether equipment is considered valid.
· Write and review validation/qualification protocols and reports.
· Interact and coordinate compliance efforts with other departments including Operations, Engineering, QA, laboratories (QC and R&D) to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
REQUIREMENTS
· B.c degree in Chemistry, Pharmacy, Engineering or related Science.
· At least 5 years’ proven experience in pharmaceutical or other highly regulated industry.
· Knowledge in bioprocess equipment and their relent parameters.
· Knowledge of regulated biotechnology or drug validation requirements.
· Knowledge of manufacturing processes, sampling techniques, government regulations and guidelines pertaining to those areas.
· Strong understanding of cGMPs and validation/qualification concepts.