A Head of Quality Is required for a pharma company based in West Dublin.
As well as overseeing commercial release the successful candidate will also be instrumental in setting up new state of the art lab. This lab is a sign of the companies continued growth.
Reporting to the EU Operations Director, this is a key accountable role as a Qualified Person (QP) responsible for the day to day management of full compliance and quality assurance/control requirements specifically within the Pharmaceutical Industry. Excellent commercial acumen with the ability to collaborate and communicate at various levels and supporting operational excellence; as well as representing the company as the Qualified Person (Primary) in the EU. A resilient people leader to change, with the ability to make "best for the business" decisions effectively and readily; with responsibility for quality cost/awareness and budgetary control.
Management of Quality Assurance Function
- Responsibility for the day to day management of the Compliance/ Quality Assurance functions within the Company.
- Line management responsibilities for the QA Executive, Compliance Executive, QA Documentation Controller and QA Inspectors.
- Hosting both Regulatory and Customer Audits with 100% involvement and participation. Ensure a state of constant readiness for unannounced regulatory inspections. Producing reports on the audits and ensuring corrective actions that may arise as a result of the audits are implemented.
- Act as Qualified Person (Primary) on behalf of the company - responsible for the review of batch manufacturing records, process deviations, LIRs and disposition of the same in line with Directive 2001/83/C as amended by Directive 2004/27/EC and described in Annex 16 of the EU Guide to GMP.
- Provide QA support for EU importation of pharmaceutical products, and batch release for the EU Market.
Lead and develop
- Manage the training and professional development of QA employees, ensuring that training needs are identified and personal development programmes are implemented on an annual basis. Conduct performance appraisal with all direct reports on an annual basis.
- Managing the training and professional development of staff in a harmonious and productive environment.
Support Operational Excellence
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Manage relationships with Partners and Vendors for Quality related activities, including being key company contact person for such relationships
- Assist with troubleshooting quality issues at Partner's or vendor's site or associated with technology transfer, when required.
- Integrate, contribute, and/or lead cross-functional project teams as required. Support projects schedules as required.
Audit and assessment
- Preparation and execution of Risk Assessment studies.
- Investigation and review of OOS validation results. Reporting of all investigations in line with procedures.
- 100% Participation in Regulatory and Customer Audits. Ensure a state of constant readiness for unannounced regulatory inspections. Produce reports on the audits and ensure that appropriate CAPAs are implemented where necessary.
Quality Management System
Responsibility for Management of the;
- Change Control System.
- Documentation Control System.
- Deviation Control System: ensuring deviations are recorded, discussed via regular scheduled meetings and corrective actions agreed and implemented in a timely manner.
- Customer Complaint System.
- Vendor Complaint System.
- Internal Audit System: ensuring that any corrective actions /deviations /process (procedure) changes are properly documented and executed
- Vendor /Contractor audit program; schedule and participate in routine vendor audits and vendor qualification audits
- Product Quality Review System.
- GMP training program.
- Ensuring that all batch card QA review is scheduled, completed on time and logged.
- Review and approval of SOPs, SAMs, Artwork and Specifications.
Quality Control Laboratory Management
- Lead and coordinate the activities within the QC Chemistry and Microbiology Laboratories, in line with internal, external and statutory requirements.
- Review, and ascertain knowledge of laboratory practices, methods and operation; with a view to implementing changes which will enhance the operation and efficiency of the area.
- Ensure that existing and new equipment, facility and processes, are validated/calibrated on a regular basis and system is maintained for GLP / GMP compliance.
- Manage and participate in projects as the laboratory representative to meet business and compliance objectives, including modernisation of laboratory facilities.
- Liaise with other departments (specifically research and development) with regard to technical upgrades and new product developments
- Participate in GMP audits carried out by customers and regulatory authorities. Produce audit reports and ensure corrective action closeout after audit. Support the QA auditors in ensuring GMP compliance both within the company and at its key suppliers.
- Ensures that documentation related to raw materials, stability samples and finished products comply with EU regulatory requirements. Implement continuous improvement/cost awareness budgetary control
- Significant experience (5+years) leading a team within the quality assurance / quality control / compliance functions of the pharmaceutical industry.
- BSc Degree in Chemistry, biology, Pharmaceutical or related discipline,
- Qualified Person (QP) in Pharmaceutical Manufacturing Technology
- Practical experience acting as Qualified Person releasing product into the Irish and European Markets
- Thorough understanding of quality systems and cGMPs.
- Experience interfacing with regulatory bodies or working on regulatory submissions
- Effective at working in fast-paced environments, specifically in a leadership capacity to facilitate objective decision making
- Experience with and fundamental understanding of EMA regulations and associated guidance documents
- Experience leading GMP audits, including drug product manufacturing and analytical testing.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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