Quality Manager, Process QM - Head of Quality Control

PAREXEL International

Sun, 18 Dec 2016 12:04:40 GMT


Key Accountabilities • Identify process improvement opportunities and champion their implementation, as assigned. • Work independently and provide expert advice to groups within the organization. • Provide mentoring, leadership, direction and training to new and existing (Senior) Quality Specialists. • Participate in SOP and process development as assigned.

  • Participate in development of quality-related processes and tools. • Provide quality consultancy to Functional Leads, Line Manager and/or Project Leader/project leadership). Accountabilities as Head of QC in depots/warehouses: • May execute QC checks of Medicinal Products and other quality critical Clinical Trial Materials during receipt, production and distribution • Oversee all Quality Control activities in local depot/warehouse • Instruct and train QC staff and other depot staff as needed • Perform QC release of Medicinal Product batches and batches of other quality critical Clinical Trial Materials (CTM) • Oversee premise and equipment (P&E) maintenance and cleaning • Approve Product Specifications and Master Batch Records • Review and approve Production Batch Records and Test Records • Perform and support P&E qualification/validation activities as appropriate • Undertake local P&E Quality tasks as defined in PAREXEL procedures to cover local QA tasks • Oversee local depot and production (D&P) related change control procedures and quality issue (QI) reporting • Closely co-operate with local Head of Production, (Sr.) Depot Coordinator and local QP (Qualified Person) or local RP (Responsible Pharmacist) to ensure smooth depot/warehouse operations • Closely co-operate with (Sr.) GMP Lead to ensure worldwide harmonization • Work with the relevant training functions including PAREXEL Academy/Learning & Development and Operations. Assist with the development or enhancement of training materials, as assigned.
  • Complete or oversee the completion of assigned quality interventions/targeted/independent quality assessments. Verify compliance with GxP guidelines, local regulations, protocol, PAREXEL procedures and/or sponsor requirements. • Develop designated operational group(s) specific interventions/targeted/independent quality assessments as assigned. • Provide audit and inspection support as assigned.
This may include: providing assistance/advice for audit/inspection preparation; representing Quality Management in audits and inspections as required; reviewing assigned audit/inspection responses. Request audits of investigational sites, local offices or processes as needed. • Provide support for management of quality issues. Facilitate and advise on corrections and corrective actions related to designated quality issues.

Develop preventive actions and ensure resolution by Operational or Line Management staff, or Quality Management. Facilitate local compliance to the corrective and preventive action (CAPA) program. • Attend (or where required, lead) internal quality-focused meetings. • Maintain a familiarity with PAREXEL project-related systems and related processes.

  • Perform other assigned process, quality or training related tasks for particular workgroups (e.g. Line Managers, Leads) or project teams as assigned. • Remain informed about developments in relevant regulations and guidelines. • Share information in an open, balanced and objective manner with other Quality Management and other PAREXEL professionals to maintain positive, results-oriented team environment.
  • Deputize for manager as assigned. • International travel required of approx. 10%

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