QA API Specialist (Biologics)

25 Jul 2018
22 Aug 2018
Chris Sowden
Contract Type
Full Time
Hyper Recruitment Solutions are currently looking for a QA API (Biologics) Specialist to join a leading Pharmaceutical company in Iceland. As the QA API Specialist (Biologics) you will be responsible for supporting the QA function in several key critical areas to maintain GMP compliance.


Your duties as the QA API Specialist will be varied however the key duties and responsibilities are as follows:

1. You will play a key role in the build, design and qualification of a pharmaceutical process, this will require an understanding of process step design using equipment focussing on fermentation for example bio-reactors, monoclonal antibody downstream processing filling in vials and pre-filled syringes.

2. The QA Specialist will utilise the equipment life cycle approach with the aim of ensuring a GMP compliant facility is made operational, you will use problem solving and root cause analysis tools to achieve this and employ a risk based approach.

3. You will understand Good Engineering Practice and how it relates to GMP with excellent knowledge og GMP start up and systems implementation.

4. You will be possess excellent communication and team working skills and be flexible when it comes to travel.


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

1. Relevant degree in a life science related discipline

2. Proven industry experience in the Pharmaceutical Industry of at least 10 years.

3. A working knowledge and practical experience with Biological products and the customer interface of the Pharmaceutical industry 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 | New Build | Commisioning | Equipment Qualification | Site Start Up | Implementation | Good Engineering Practice.

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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