Posted on 09/05/16
£16k - £18.5k
Our client, already well-established in Asia, is launching a new venture in East Kent in the production of bulk pharmaceutical products using environmentally sustainable methods of production. This pioneering manufacturer is developing its operation to include UK and European markets. Initially, we are recruiting for a QA Administrator for this ground-breaking, innovative organisation providing a chance for successfully selected candidates to be involved at its inception. The successful start-up team will be committed, driven, hardworking and enthusiastic and will play key roles in ensuring the success of this exciting venture.
Overall purpose of the job:
Supporting the QA team in compliance activities, such as; document administration, processing complaints and supporting change controls and incident investigation.
- Review of all QA documentation.
- Administration of the Site SOP system.
- Maintain document control over all relevant documentation including, but not limited to change control and QMS.
- Ensuring compliance with GMP as set out in Eudralex vol IV and ICH guidelines.
- Ensure all records are filed in compliance with GMP standards.
- To promote quality performance improvement.
- To produce data and report on performance, measuring actual performance against set indicators.
- To identify quality issues and improvements.
- To assist with product complaints or recalls.
- To support the QA team preparing for internal and external audits.
- Management of CAPAS, deviation controls and follow-up action plans.
- Prepare SOPs and other quality documents.
- To undertake project work when required.
- Build authentic relationships with all related departments.
- Degree level education or equivalent
Knowledge and Experience
- Highly effective written and verbal communication skills
- Well organized, detail oriented, able to manage multiple competing tasks effectively, efficient and able to work independently and think critically
- Ability to review both internal and external (including customer-facing and MHRA) communications to ensure that they fully comply with all pertinent laws and regulations and do not result in any compliance related risk.
- Previous experience within Quality Assurance of API manufacturing company is preferred
Skills & Abilities
- Self-motivated with ability to work proactively using own initiative
- A credible and confident communicator (written and verbal) at all levels
- Good IT skills e.g. Microsoft Office (Word, Excel)
- A flexible and adaptive team player.
- Attention to detail.
Due to the high volume of applicants applying for all roles, we can only reply to candidates with the most relevant skills and experience. If you have not heard back from us within 48 hours of your application please assume that you have been unsuccessful on this occasion.