QA Compliance Specialist
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| Job Type | Contractor |
| Area | Sligo, Ireland |
| Sector | QualityOperations & ManufacturingRegulatoryEHS |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1003130 |
| Job Views | 854 |
- Description
- Team Horizon is seeking a QA Compliance Specialist for our client based in Sligo.The QA Compliance Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all.
regulatory requirements. The QA Compliance Specialist will have responsibility to assess and report on the effectiveness of the quality system to senior management.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Coordinating the quality system, ensuring full compliance by all personnel with its requirements.
Coordination of Product Quality Reviews activities.
Management of all Technical Agreements from initiation, review, approval and storage.
Coordination and Management of all Track and Trend activities to support Manufacturing and QC.
Driving a QRM approach to all activities on site.
Coordination and facilitation of all Site RCS and FMEA activities.
Auditing the quality system per the documented internal audit schedule.
Assisting in the documentation, investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary.
Ensuring that products manufactured on site meet requirements of end users, of regulatory authorities and of the company.
Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings.
Coordinating change management, change control and Change planning activities.
Monitoring quality performance and advising management personnel on major quality issues.
Liaison with Global Quality Assurance, FDA, HPRA and other regulatory bodies.
Regulatory review.
Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required.
Establishing Corrective / Preventive Action system and procedures.
Management of the Supplier program including the ASL, Performance metrics and Audit Schedules
Creation and approval of commodity specifications as required.
Performance of Vendor audits as required.
Supporting all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
Adheres to and supports all EHS & E standards, procedures and policies.
What you need to apply:
Third level degree in a science, quality or engineering discipline.
Experience in Pharmaceutical or Sterile Manufacturing
A minimum of three years’ experience in a quality/operations role in a highly regulated manufacturing GMP environment (Pharmaceutical /Biologics/Medical Device)
A strong knowledge of regulatory requirements is required. Cognitive Skills Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
Requires proven problem-solving skills and the ability to adapt to new regulatory requirements. Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
Must be results driven and accountable striving to meet all targets and metric standards as set by site/department and division leaders.
Requires total commitment to quality and maintaining a high standard of work at all times. Demonstrates the highest levels of integrity and a strong work ethic at all times.
Strong communication skills both verbal and written are required for the execution of this role.
Strong interpersonal skills are required. Supports the principles of Perfect Performance
