Description
My client based in Dublin, a leading pharmaceutical company, have an urgent requirement for Senior Quality Assurance Specialist.This would be a 5 month contract position and is a 20 hour working week. The successful candidate will be responsible for ensuring all appropriate
batch related documents and finished product packs are available from the suppliers to enable the release of products for supply to the global market.
This role provides an excellent opportunity for flexible working hours and excellent compensation
Responsibilities:
1. Perform batch record review and release in an efficient and timely manner; assure non-conformances are properly investigated and explained, and calculations are correct.
Assure that finished product is not released until the appropriate release testing and batch record review has been performed. (40%)
2. Review finished product packs and batch documentation and check against the registered specifications prior to market release or advising rejection of a batch. (20%)
3. Track and evaluate any investigations or deviations that occur during the manufacture of GMP material.
When the non-conformance is more serious, bring it to the manager's attention and aid in requesting a plan of action for a more extensive investigation. (20%)
4. Assist with ensuring change control requirements impacting batch release are met. (10%)
5. When appropriate, assist in internal GMP audits, and regulatory inspections regarding marketed products. (5%)
6. Represent GQA on project teams as appropriate (5%)
7. Participate in meetings regarding Marketed Product and give input on QA issues.
8. Be able to follow through an investigation, ask all relevant questions to gain sufficient information to enable a decision on the status of the product to be made
9. Be able to consider an issue in totality - impact on other batches, other products, supply / stock issues.
10. Be able to interact effectively with other functional areas in order to represent GQA in cross functional projects
12. Strong risk assessment skills.
Education and Experience
1. University degree in scientific discipline
2. Minimum 3 years GMP experience. Quality Assurance exposure is highly desirable
3. Candidate should be familiar with GMP environment and familiar with EU/US GMP regulations
4. Strong communication and technical writing skills required
5. Prior experience using SAP is desired
If you feel you would be a good fit for this role or know somebody who would be, please apply directly to this advert or contact me Derek Sheridan on ASAP for further information.
To find out more about Real please visit www.realstaffing.com