Senior Quality Manager, Qualified Person
Venn Group is currently working with a Large Pharmaceutical Company in the South who are looking for an Senior Quality Manager, Qualified Person to join their Team.
The Person will be responsible for:
- Overall management for the day to day running of the Quality Assurance Department and its staff. Act as deputy Management Representative for the Director of Quality in their absence.
- Management of the Quality Leads, QA Specialists and QA Officers. Direct line manager responsibility performance and development of quality personnel.
- To act as a QP on the licence and carryout batch certification in accordance with the current regulatory guidelines.
- The maintenance, management and organisation of Quality Assurance matters for the site. Leading the team to ensure that departmental objectives are implemented in line with the overall Quality/Corporate goals.
- Lead the development and maintenance of the Company’s Quality System to meet the requirements of the relevant regulatory authorities for medical devices and pharmaceutical products (e.g. MHRA, Notified Bodies and ISO Standards, as applicable) and all other applicable quality and regulatory standards. Liaise with RA in compiling application for regulatory approval.
- Actively participate in preparation and approval of site documentation including policies, procedures and associated reports, as well as annual reviews when required.
- Act as a lead auditor for the GMP audit/inspection program for the facility, systems (including automation systems) and operations in supported areas. Support the external suppliers audit schedule.
- Play a leading role in quality system audits of the site by regulatory bodies or customers.
- Promote GMP awareness at the site.
- Develop and maintain a quality training process and provide training and support to departments.
- Develop a culture of continual improvements within the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
- Leading an effective CAPA system, including investigations, root cause analysis, risk assessments and implementation of change controls and CAPAs as appropriate.
- As part of the Quality Review Board, oversee the evaluation of Non Conformance and Customer Complaints ensuring adequate and timely closure and control of affected product.
- QA representation (as required) on the Product Vigilance Committee.
- Review and document Change Control Requests, ensuring compliance with cGMP and quality standard requirements.
- Responsible for the Risk Management process of pharmaceutical products and manufacturing processes.
- Identification and collection of data for Quality Metrics for Management Review. Preparation of reports and presentation to the Director of Quality and Management.
- Carry out other reasonable tasks as required by the Line Manager
Contract Duration: 6 months initially
If you are interested in this position please send your updated CV to firstname.lastname@example.org or call me 020 7557 7667.