An exciting opportunity has become available for a QA Associate to join a leading Biopharmaceutical company based in the Hertfordshire area. As the QA Associate, you will be responsible for reviewing and auditing manufacturing batch records to ensure adherence to procedures, policies and GMP requirements. You will also initiate and assist with deviation and CAPA records, working with QP's to support disposition decisions.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Associate will be varied, however the key duties and responsibilities are as follows:
1. You will need to participate in daily updates for batch release priority and complete GMP reviews for the batch documents in a timely manner in line with manufacturing schedules. Significant GMP and patient safety concerns would need to be highlighted to a supervisor or QP's as required.
2. To participate in Regulatory and customer audits as well as performing regular manufacturing facility audits, contributing to continuous improvement activities.
3. As QA Associate, you will also assist with progression of regulatory actions, customer complaints, GDP incidents where required.
4. Work related to job objectives as directed by QA management will be undertaken and you will assist with deviations and changes to batch review, assessing them on behalf of the QP.
To be successful in your application to this exciting opportunity as the QA Associate we are looking to identify the following on your profile and past history:
1. The successful candidate will hold a relevant degree in a scientific discipline or equivalent.
2. You will have proven industry experience of working within a biopharmaceutical, clean room or manufacturing environment and working with documentation. Working with documentation and Quality Management Systems (QMS) would also be desirable experience.
3. A working knowledge with sterile aseptic filling and packing manufacturing processes is desirable, as well as practical experience with blood products. You will be required to have a natural tendency towards continuous improvement.
Key Words: Quality Assurance | QA | Associate | Audits | GMP | Biopharmaceutical | CAPA | Deviation | manufacturing | Quality Management Systems | QMS
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.