Provide continuity for the validation program for assigned plant or functional area by writing, reviewing and approving validation documentation. Other duties may be assigned
ACCOUNTABILITIES:
- Responsible for assuring compliance to West Pharmaceutical Systems validation program.
- Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, regulatory bodies, manufacturing plants, research & development, IT and laboratory groups.
- Provide guidance to system/process stakeholders for validation documents, as to content and format of validation life cycle documentation.
- Write protocols and reports directly related to QA, e.g. (statistical sampling plans, assessment criteria (Validation Rationale), compliance, guidelines, specifications, etc.).
- Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports.
- Provide guidance during protocol incident process, including reporting, investigations and approval of resolutions.
- Utilize engineering, vendor, and customer specifications to generate and execute testing protocols for equipment following West and customer procedures and good documentation practices.
- Strong attention to detail and knowledge of pharmaceutical processes and protocol around automation processes, equipment, and systems.
- Keep current with the industry standard practices and FDA requirements for validation.
- Write/revise validation templates and validation plans.
- Meet agreed to project deadlines
BASIC QUALIFICATIONS:
Minimum Bachelor of Science Degree in Engineering or Science.
Minimum 3-5 years of experience writing, approving and executing validation protocols and reports, specifically in the following areas: Process Validation, Sterilization, Equipment/Utility Qualification and Computer System Validation. Ability to comprehend computer systems applications and business/manufacturing processes. Excellent written and verbal communication skills, good problem solving skills, and ability to function as a team member and leader.