Quality Manager R&D Compliance, Open to flexibility
Quality Manager R&D Compliance, Open to flexibility
The role provides oversight and assurance to management for the level of compliance of CHR&D sites and vendors through the assessment processes. The role also provides support for CHR&D projects, training and ensures that CHR&D sites and vendors are inspection / audit ready.
Plans and conducts global audits independently or as a team in a lead or support role to ensure that robust processes are fully developed to meet the requirements of Good Manufacturing Practices (GMP's).
- Lead audits of Consumer Healthcare R&D(CHRD) facilities & processes and vendors. Ensure that senior management is apprised of identified key risks together with their root causes and that appropriate corrective and preventative action plans are prepared and implemented.
- Lead or assist management in performing of risk assessments, planning, co-ordination and conducting of complex assessments.
- Maintain information in GSK audit database system and perform trending / analysis of Findings and Corrective Actions and Preventative Actions (CAPA's).
- Review and assess corrective and preventative action plans and ensure timely closure of CAPA's as per GSK policies and procedures.
- Ensure CHRD sites and vendors are inspection ready, and assist CHRD management in hosting and supporting Regulatory agency inspections at CHRD facilities.
- Maintain current awareness of the GSK organization, its expectations and strategic direction.
- Represent and promote CHRD Quality both internally and externally through interactions with regulatory agencies, external auditors, professional bodies and associations and customers.
- Build effective working relationships with customers
- Proactively engage in implementing continuous improvement activities within CHRD.
- Lead or participate in the design and development of departmental or global processes
- Maintain current awareness and knowledge of global regulatory requirements, GSK QMS and CH SOPs, and ensure CHRD procedures meets appropriate regulatory requirements.
- Organise and implement training of CHRD Quality and CHRD staff for awareness of current regulatory requirements including regulatory expectations, inspection readiness and/or GSK corporate expectations.
- Provide training to other CHRD Compliance staff in assessment processes including planning, conducting, analysing and reporting assessments as required.
- Represent CHRD Quality at the Quality Council (QC) meetings or Projects as required.
10 years of pharmaceutical industry experience with at least 3 to 5 years in GMP auditing. Working knowledge of applicable GMP regulations including Medical Devices and associated guidelines.
- GxP Auditor Certification from an accredited agency or GSK sanctioned recognised authority
- Working knowledge of applicable GMP and Regulatory Affairs regulations and guidelines
- Experience working in global and multidisciplinary environments
- Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems (e.g., Trackwise) and regulatory submission management submissions
- Willingness to travel worldwide, sometimes at short notice
You may apply for this position online by selecting the Apply now button.
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