Location: St. Petersburg, FL
FUNCTION: 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:
1. Responsible for assuring compliance to West Pharmaceutical Systems Division, America?s validation program.
2. 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.
3. Provide guidance to system/process stakeholders for validation documents, as to content and format of validation life cycle documentation.
4. Write protocols and reports directly related to QA, e.g. (statistical sampling plans, assessment criteria (Validation Rationale), compliance, guidelines, specifications, etc.).
5. Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports .
6. Provide guidance during protocol incident process, including reporting, investigations and approval of resolutions.
7. Keep current with the industry standard practices and FDA requirements for validation.
8. Write/revise validation templates and validation plans.
9. Meet agreed to project deadlines
10. Other duties as assigned.
Requirements:
BASIC QUALIFICATIONS:
Education: Minimum Bachelor of Science Degree in Engineering or Science
Experience: Minimum 5 years of experience writing, approving and executing validation protocols and reports, specifically in the following areas: Process Validation,Steam 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.
West Pharmaceutical Services is an Equal Opportunity Employer
Click Here to Apply
1. Responsible for assuring compliance to West Pharmaceutical Systems Division, America?s validation program.
2. 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.
3. Provide guidance to system/process stakeholders for validation documents, as to content and format of validation life cycle documentation.
4. Write protocols and reports directly related to QA, e.g. (statistical sampling plans, assessment criteria (Validation Rationale), compliance, guidelines, specifications, etc.).
5. Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports .
6. Provide guidance during protocol incident process, including reporting, investigations and approval of resolutions.
7. Keep current with the industry standard practices and FDA requirements for validation.
8. Write/revise validation templates and validation plans.
9. Meet agreed to project deadlines
10. Other duties as assigned.
Requirements:
BASIC QUALIFICATIONS:
Education: Minimum Bachelor of Science Degree in Engineering or Science
Experience: Minimum 5 years of experience writing, approving and executing validation protocols and reports, specifically in the following areas: Process Validation,Steam 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.
West Pharmaceutical Services is an Equal Opportunity Employer
Click Here to Apply
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