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QA Officer – GMP Batch Documents and Release

QA Officer – GMP Batch Documents and Release

Job Title: QA Officer – GMP Batch Documents and Release
Contract Type: Permanent
Location: Worthing
Industry:
Salary: £Competitive Salary & Benefits
Start Date: ASAP
Reference: 15766 ST
Contact Name: Steve Twinley
Contact Email: pharma.jobs@nextphaserecruitment.com
Job Published: February 09, 2018 17:06

Job Description

Do you have a scientific degree and some QA experience relating to GMP, including document control, technical agreements, complaints, batch release and auditing? Based in Worthing, West Sussex and due to continued expansion, a new opportunity has arisen for a QA Officer with an innovative Pharmaceutical company. If you have a solid grounding in GMP regulations and Quality activities, especially relating to GMP documentation and the processing of batch records, this is an excellent opening to consolidate and progress your career.

The company offers a competitive salary, based on experience, and will consider people at a more junior level such as graduates with around a years’ experience, or individuals with more significant experience in auditing and writing technical / quality agreements. You will work in a supportive and friendly environment where achievement and ambition are appreciated, recognised and rewarded.

The Company

The company is a pioneering UK owned Pharmaceutical organisation specialising in the treatment and prevention of allergies. Their focus is on the vaccination and prevention of a wide range of conditions including hay fever and their products are fascinating, complex and ever-progressing. The company employs around 270 people in Worthing across GMP, GLP and GDP areas (including sterile drug production, in both bulk and patient-specific batches) and has built an excellent reputation for providing career developing opportunities, challenging and engaging project work plus a pleasant, vibrant working environment.

The Role

You will join a busy QA department that supports all company activities with close links to Manufacturing, Packaging, Validation, QC and Product Development, Sales & Marketing and Regulatory Affairs. The department is split into two teams and this role is in the group focused on Quality Systems, QA Documentation and Batch Record processing. Using your skills to the full, you will review patient-specific batch records, process customer complaints (using Trackwise), maintain systems compliance, support change control, filing and review, prepare and issue QA technical agreements, analyse data, support the Document Control function and undertake a range of other responsibilities relating to continuous improvement. In addition, you will have the opportunity to expand into other areas of Quality Assurance activities. As you get more experienced, you will also take more and more of a lead role in auditing (internal and / or external), and your determination and driven nature will be highly rewarded.

This is a broad, challenging role that requires meticulous attention to detail, strong communication skills and the ability to multitask. Full details will be provided on application.

Benefits

  • Very competitive salary (to be discussed on application)
  • 25 days' holiday
  • Flexible working hours
  • Private medical cover
  • Discretionary, non-contractual annual bonus
  • Stakeholder pension plan
  • Life insurance scheme
  • Long term disability scheme
  • Commutable by car with free parking or walking distance of train station / bus routes

Experience

We are inviting candidates with a strong scientific / technical / engineering background (ideally a degree), with experience gained in a GMP / GDP / GLP environment. Knowledge of QA processes and systems, combined with experience of batch record processing, would be a strong advantage. You will demonstrate the ability to multitask, use basic statistical tools and methods plus display data graphically. In addition, you will need a strong and enthusiastic work ethic, excellent communication skills and enjoy a closely-knit team environment. Previous auditing training would be preferred but is not essential.

Keywords

QA Officer, Quality Assurance, GMP, cGMP, Good Manufacturing Practice, QC, GLP, GCP, GDP, Quality, Pharmaceutical Quality Systems, QP Release, Batch Review, Batch Release, Data Management, Statistics, Sterile, Aseptic, West Sussex, Worthing, Brighton, Hove, Horsham, Crawley, Haywards Heath, Burgess Hill

This is a permanent role