Incoming QA Associate
Julie Marshall at CK Group is recruiting for an Incoming QA 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.
The IQA Senior Associate will be responsible for sampling and testing of incoming raw materials/excipients and components.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Senior Associates may be asked to carry out additional work functions to support site continuous improvement activities. You will be responsible for:
• Performing Sampling of Incoming Raw Materials and Components in accordance with site procedure and ANSI standards
• Clean room raw material Sampling required in accordance with procedural requirements
• Proficiency in ANSI sampling of excipients, chemicals, primary and secondary packaging.
• Inspect Raw Materials and Components in accordance with site procedures
• Send Samples for Test to QC or Contract Laboratories in accordance with material Specifications
• Compile, Review/approve incoming batch related documentation and associated documentation in preparation for disposition activities.
• Perform all activities in compliance with company safety standards and SOPs
• Write, review and approve Standard Operating Procedures in accordance with company Policies.
• Provide Quality support for triage and investigation of non-conformances (NC's)
• Responsible for drafting NC's and CAPA's
• Participates in customer complaint investigations as required.
• Provides training and advice to staff in order for them to perform their desired functions.
• Maintain the site reserve/retain samples program
• Review and approve cGMP records (e.g., WO, JP, GDMS, 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.
Degree (or equivalent) in Engineering or Science related discipline preferred.
Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Excellent written and verbal communication skills.
Experience working with dynamic cross-functional teams and proven abilities in decision making.
Strong organisational 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.
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 46471 in all correspondence.
Posted 14 days ago