Plant Quality Assurance (PQA) Snr Associate - Dun Laoghaire
CK Group is recruiting for a Plant Quality Assurance (PQA) Snr Associate to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis.
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.
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.
A variety of shift patterns may be required to support manufacturing operations, including but not limited to day shift, 16/5 shift OR 24/5 shift
Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
Key Responsibilities include:
- Perform all activities in compliance with Amgen safety standards and SOPs
- Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
- Provide Quality support for triage and investigation of all classes of non-conformance (NC) events
- Review and approval of NC1s and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
- Participates in customer complaint investigations.
- Provides training and advice to staff in order for them to perform their desired functions.
- Perform Visual Inspection AQL inspections and provide quality oversight for the inspection program
- Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
- Review and approve cGMP records (e.g., NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
- Support continuous improvement and Operational Excellence initiatives
- Any other tasks/projects assigned as per manager's request.
Basic Qualifications & Experience required includes:
- University degree. Engineering or Science related discipline preferred.
- Relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications & Experience required includes:
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and proven abilities in decision making
- Strong organizational skills, including ability to follow assignments through to completion
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
- Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
- Operational Excellence experience
For more information or to apply for this position, please contact Jenni on 01438 768710 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 45530 in all correspondence.