Leading pharmaceutical manufacturer now seek an experienced QA Specialist for a 12-Month contract. This specific role is required to perform QA review of manufacturing and engineering records & associated documents and QA review & approval of procedures and GMP deviations.
- Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
- Reviews routine manufacturing and engineering documentation including batch manufacturing records
- Assists in the completion of Manufacturing related customer complaint investigation
- Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
- Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
- Review and approval of GMP Deviation investigations and CAPAs
- Identifies problems and generates alternatives and recommendations
- Completion of routine/non-routine to more complex projects/assignments
- Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP
- Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings
- Normally receives very little instruction on routine work, general instructions on new assignments
Education, Knowledge and Skills:
- 4+ years of relevant experience in a GMP environment related field and a BS.
- 2 + years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
- Good verbal, written, and interpersonal communication skills.
- Proficiency in Microsoft Office applications.
12-month Fixed Term Contract
For a confidential discussion on this or any other current opportunity please contact Nicola Murphy on 021 233 9200 / [email protected]
Please note that your application for this vacancy will be forwarded to all the consultants in The Logiskills Group as you may be suitable for other roles that we are unable to advertise.
Our latest vacancies are now advertised on our Twitter Feed @LogiskillsJobs