- Prior experience in pharmaceutical industry (7 years minimum).
- Minimum of 3 years management or supervisory experience including matrix environments or managing contractors.
- BS/BA required. A degree in engineering, biology, chemistry or related scientific discipline.
- Validation experience is required.
- Process Equipment knowledge.
- Familiarity with Good Manufacturing Practices and Regulations governing validation activities.
- Prior interfacing with regulatory agencies.
- Sense of urgency, flexibility and accountability.
- Executive capability and leadership to manage people and field projects teams.
- Must be able to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
- Must have demonstrated self-direct work habits and strong communication skills.
- Must be a committed team player prepared to work in and embrace a team based culture.
- Familiarity with regulatory expectations regarding electronic records and electronic signatures.
- Proven record of providing excellent internal and external customer service.
- Maintain attention to detail, while completing multiple or repetitive tasks.
- Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.
The Validation Supervisor will be primarily accountable to ensure the entire site and all GMP systems operate in a fully validated state. Provides technical support for utility systems (including purified water systems, WFI, compressed air systems, HVAC and clean steam systems); process; and provide input necessary to establish technical standards (technical specifications) in compliance with GMP and GSK requirements. Develop and implement templates for standard and specific qualifications (IQ/OQ/PQ protocols) for site equipment and systems in order to comply with validation policies and regulatory compliance requirements. Define, develop, analyze and approve specific validation plans or strategies for projects or minor upgrades of site related equipment. Insure compliance readiness for Level 3 audits, Level 4 inspections and provide adequate support to inspected departments prior to and during the audit process. Develop skills of validation staff in order to ensure technical and regulatory expertise to ensure validation support for all GSK Hamilton projects including IQ, OQ, and PQ protocol development and support of execution. Manage the site Validation Department and assure that the site Validation Master Plan is developed and maintained. Provide direct technical support to the value streams through the deployment of Subject Matter Experts from the technical team. As a member of the Local MSAT department, be responsible for the validation department results. Ensure personal objectives are aligned with site goals and objectives.
You may apply for this position online by selecting the Apply now button.
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