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.