Senior Quality Compliance Officer

We are currently looking for a Senior Quality Compliance Officer to join a leading Pharmaceutical company based in Northern Ireland.

Role Overview:
To assist departments across one of our client's major divisions in the development and improvement of policies and procedures associated with the strategic development of the Quality System. In addition the post holder will provide Quality support to late phase clinical trial and commercial API manufacturing projects to ensure compliance to customer and regulatory requirements.

Responsibilities:
Act as a GMP advisor to all departments.
Actively contribute to the development, implementation and maintenance of the Quality System in production, laboratory, validation and other GMP areas
Where directed by Line Manager, supervise and mentor Quality Compliance Officers and quality unit support staff
Provide quality assurance support to manufacturing and analytical contracts
Actively participate in and promote GMP improvement initiatives throughout the division
Ensure that the Quality System is maintained in line with cGMP, ICH Guidelines, GAMP and other relevant regulatory requirements
Assist in the development and maintenance of a quality culture of continuous improvement through leading by example
Assist in the development of a strategy to meet the requirements of Regulatory Statutory Inspections such as FDA and MHRA
Develop policies and procedures and their associated documentation in compliance with Regulatory requirements and industry standards
Provide training to divisional personnel in GMP policies and procedures
Review manufacturing and analytical data associated with the release of GMP intermediates, APIs and IMPs, to include monitoring, review and approval of: Manufacturing records (Manufacturing Directions, MDs), Analytical summary results, Corrective and preventative (CAPA) investigations, Specifications, Cleaning records.
Represent QA on Manufacturing and Analytical project teams as assigned by the Line Manager, taking responsibility for quality aspects of that project, communication to the Project Team and communication of any quality issues to the Line Manager
Participate in process Validation projects on behalf of QA
Participate in Change Control review meetings for changes associated with validated processes
Participate in Quality Systems required for the management and control of suppliers and contractors such as raw material suppliers and analytical sub-contractors (this may involve assessment and audit of suppliers)
Participate in and lead quality investigations, ensuring that effective CAPA actions are implemented
Review and approve protocols and reports such as those generated for stability studies and analytical method validation
Conduct internal audits and QA walkthroughs in order to verify compliance with the principles of GMP and our client's procedures, ensuring that audit findings are documented and corrective actions are agreed, documented and implemented in a timely manner
Bring the outcome of continuous improvement quality activities such as internal audits, complaints, quality incidents and deviation investigation to the attention of Managers and agree effective preventative actions
Conduct investigations of quality related customer complaints and ensure effective remedial actions are implemented
Participate and, where necessary, host external audits by customers and Regulatory Authorities
Where required, write, approve or authorise SOPs and regularly review SOPs to ensure their continual effectiveness and compliance with the principles of cGMP
Develop and deliver training on Quality Systems/procedures to colleagues throughout the division, developing and delivering GMP awareness and improvement training as directed by Line Manager
Review and assess Technical and/or Quality Agreements for customers and suppliers as and when required, ensuring awareness of Technical and Quality Agreements in place with customers and promoting compliance with such agreements within manufacturing and analytical contracts
Promote and maintain a high standard of customer care, participating in customer visits as required

Requirements:

QUALIFICATIONS
BSc level (or equivalent) qualification within a Life Sciences related discipline incorporating some knowledge of chemistry and/or analytical ideally Previous formal training in the area of GMP leading to a demonstrable awareness in the key principles of GMP management
Previous experience within a QA role within a pharmaceutical facility manufacturing APIs compliant with GMP principles. APi experience is essential.
Previous practical experience in the preparation and approval of Quality policies and procedures
Previous experience of data review and release of manufacturing and/or analytical reports and studies
Previous experience within a QA role within a pharmaceutical contract manufacturing facility manufacturing APIs compliant with GMP principles
Previous practical experience of process validation
Previous practical experience of supply chain management
Proven working knowledge of the principles of change control.

Matchtech Group Plc is acting as an Employment Agency in relation to this vacancy.