Telephone: 086 8395533
QA Team Leader
Our client, a pharmaceutical company in Cork are currently looking to recruit a QA Team Leader for their site.
The QA Team Leader will be responsible for the following.
- Managing compliance activities and QA operational activities related to the company as required by Good Manufacturing Practice (GMP).
- These activities include executive roles in managing commissioning and qualification, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
What you’re great at:
- Excellent interpersonal skills
- Ability to operate as part of a team is critical.
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible
- Coaching and mentoring style
- Integrity, trustworthiness and objectivity
- Knowledgeable of FDA/EMEA regulatory requirements
- Supports GMP qualification and validation activities through execution of supplier/contractor audits and directing review of qualification/validation documents providing oversight of qualification and validation programs.
- Reviews and ensures their team organizational capabilities, personnel competencies and that the number of qualified personnel continuously matches expertise and workload needed, to plan for future requirements in the area.
- Motivating and developing reports in addition to developing and setting measurable and challenging goals for the group.
- Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
- Actively participates in management of the Quality Department through budget forecasting and preparation, training of staff, and deputizing for other members of the department management team as appropriate.
- Responsible for QA staff in the development and implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
- Coordinates QA staff in the development and implementation of systems and procedures for external audits and inspection management suppliers and contractors and reporting to plant management on the state of compliance at the company. Assists Quality Director and QA Managers in management of quality inspections and audits of the company by external parties/agencies. Manages the tracking of commitments arising from audits and communication of information to site management on commitment completion.
- Gives direction to the QA Group in the execution of their duties.
- Coordinates the activities of the group within quality to create a synergistic approach to goals and tasks.
- Domestic and international travel may be required.
- Bachelor’s Degree in a scientific/technical discipline required
- A minimum of 5 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry.
- A minimum of 3 years management experience required.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations including those of FDA, IMB, EMEA and other authorities.
- Focus on patients and customers at all times.
- Advanced degree (MS, MBA, PhD) preferred
- Experience in direct interactions with regulatory agencies during site inspections.
- Experience in auditing of external suppliers, contractors and vendors.
For further information on this QA Team Leader role in Cork please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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