Quality Assurance Specialist - Dun Laoghaire, near Dublin
Jenni at CK Group is recruiting for a Quality Assurance Specialist to join a Bio-tech company in the Pharmaceutical industry at their site based in Dun Laoghaire, near Dublin on an initial 12 month contract basis.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The Role: The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. The QA Specialist will be required to be a Subject Matter Expert in their assigned area of responsibility. QA specialists will be required to understand and grasp a broad range of quality related competencies. In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
General QA Specialist Responsibilities:
- Perform all activities in compliance with Amgen safety standards and SOPs.
- Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
- Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
- Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
- Participate in customer complaint investigations.
- Provide training and advice to staff in order for them to perform their desired functions.
Your Background: Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44253 in all correspondence.