CK Group is recruiting for a Senior QA Professional 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 QA Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. QA TS Specialist will be required to understand and grasp a broad range of quality related competencies.
QA TS Specialist Responsibilities may include to:
- Provide overall quality direction and oversight for key functional areas, ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
- Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet company and regulatory expectations.
- Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, characterisation, commissioning etc.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/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 company Policies.
- Review and approval of Master Batch Records and SAP BOMS.
To be considered for the role you must have the following key skills, knowledge and experience:
- University degree, Engineering or Science related discipline preferred.
- Relevant experience working in the pharmaceutical or biotechnology industry ideally, however candidates from clinical, med device would be consideration but would need to have aptitude, self motivated with a QA or validation background.
- Experience working with dynamic cross-functional teams and proven abilities in problem solving and decision making.
- Excellent written and verbal communication skills.
- Strong organizational skills, including ability to follow assignments through to completion.
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 46246 in all correspondence.
You MUST be eligible to work in Munster. Learn more
- Agency: CK Group
- Contact: Jennifer Woolley
- Phone: 01438 743047
- Reference: 46246
- Posted: 8th August 2019
- Expires: 5th September 2019