What are the responsibilities and job description for the Manager Validation position at Wapt?
Overview
The Manager, Validation will plan, implement and coordinate equipment and facilities validation responsibilities to insure site-wide adherence to cGMPs, compendial and customer requirements for the WuXi AppTec Philadelphia operations.
Responsibilities
- Coordinate all equipment and facilities validation activities as related to plant operations.
- Review and approve all protocols, reports and studies as prepared and conducted for equipment and facilities validation.
- Perform validation assessments for all equipment and facilities related change controls.
- Review, revise and develop Standard Operating Procedures (SOPs) applicable to equipment and facilities validation and assist in the review and development of plant-wide SOPs.
- Oversee, review and approval of the site Validation Mater Plan and Validation Project Plans.
- Support the generation of risk assessments for various equipment and facilities related validation activities.
- Represent validation during agency and client audits (as needed) on matters pertaining to equipment and facilities validation responsibilities.
- Coordinate and track the corrective/preventive action follow-ups to client audits for equipment and facilities related validation issues and activities.
- Manage resource loading and manpower requirements associated with equipment and facilities validation activities or in support of internal / external client projects. This includes managing external validation resources.
- Assist with the preparation of equipment and facilities validation budget for capital projects.
- Prepare request for proposals for external equipment and facilities validation resources. Review bids and prepare bid award recommendations for upper management approval.
- Determine and coordinate the training needs of employees directly involved in the functions associated with Equipment and Facilities Validation.
- Assist with the development and tracking of the department budget.
- Periodically update the Site VP/General Manager of relevant validation activities
- Support other site departments with periodic reviews and collaboration on computer system validation, aseptic media simulation programs, and environmental monitoring programs.
- Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
- Plans, monitors, and appraises direct reports including performance competencies, goals & job results
- Coaches, counsels, and conducts disciplinary actions
- Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
Qualifications
Education / Experience:
- BS/BA in a Natural Science, Engineering or other related field
- A minimum of 10 years of relevant experience in the pharmaceutical industry in a validation or quality related position
- 2 years managing others
Knowledge / Skills / Abilities:
- Proficient in Oral & Written communication skills
- Needs to be able to read, write and understand English
- Working proficiency Microsoft Office (Word, Excel, and Projects).
- Master Control, Trackwise or related quality control software experience
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
