QA Manufacturing Expert

Location
Iceland
Salary
Competitive
Posted
06 Sep 2017
Closes
04 Oct 2017
Ref
J4366
Contact
Chris Sowden
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a QA Manufacturing Expert to join a leading Bio-Pharmaceutical company based in Iceland. As the QA Manufacturing Expert you will be responsible for providing subject matter expertise to the production team ensuring that GMP compliance is maintained.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the QA Manufacturing Expert will be varied however the key duties and responsibilities are as follows:

1. Provide general QA expertise and support for Drug Product manufacture, including writing SOP's and supporting media fill / validation activities. This will include providing QA approval of product specifications and master batch records.

2. The QA Manufacturing Expert will provide QA expertise during investigations to Deviations or OOS, identifying root cause and implementing effective CAPA's. You will support and approve change control records.

3. It will be your responsibility to review and approve all records and documentation related to continued GMP compliance within production operations, acting as a SME/author to approve Quality Documents under your area of responsibility.

4. You will be a representative for the QA department, participating in Quality projects and liaising with other departments as appropriate.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the QA Manufacturing Expert we are looking to identify the following on your profile and past history:

1. Relevant degree or sufficient experience with the production of a sterile drug product.

2. Proven industry experience in a GMP compliant environment, with exposure to the manufacture of Bio-Pharmaceuticals.

3. A working knowledge and practical experience with QA related tasks as they relate to the manufacture of sterile dosage forms would be advantageous.

Key Words: | GMP | cGMP | Quality Assurance | QA | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate | Aseptic | Biologics | Quality | Media Fills | Process Validation | Cleaning Validation | Documentation | Regulatory Inspection | SME | Subject Matter Expert | Root Cause Analysis | FDA |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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