Implementation Specialist 3

Description

Job Description: Manage Validation activities to ensure execution and review of tester protocol/test report and Master Validation Plan is conducted for medical customer account Review execution of process/tester validations, re-validations, re-qualifications any on-site projects. Manage all of the relevant parties cross functionally to ensure accurate and timely execution. Manage to review and execute validation protocols and test report and ensure that are technically correct and comply with internal and external requirement. Participate in the coordination of efforts of multi-disciplined project team on the writing, performance, documentation and approvals of validation lifecycle documentations. Manage approval of validation documentation by internal and customer on a timely basis. Manage protocols are executed as intended accordingly to the study plan/approach of process and test challenge test. Capable to provide technical expertise on manufacturing processes and validation related matter. Qualifications Required: (Education, experience, skills, etc. Please be specific) Â Â Â Â Â Â Â Â Â Â 1. Degree in Engineering / Science. 2. At least 3 years Validation Management experience ideally within the medical or pharmaceutical industry. 3. In depth knowledge of GMPs and validation. Hands on working experience on validation. 4. Good technical writing skill and communication skill is a must. Strong problem solving skills