QA Officer Chippenham, Wiltshire

Job title: QA Officer

Company: i-Pharm Consulting

Job description: Looking for a new role in Quality? Have you built up avid experience working with QMS, CAPA within a GMP environment? If so, our client here at i-Pharm is currently looking for you!

Quality is one of the forefronts of Pharmaceuticals allowing the marketing to grow and thrive as well as ensuring the company SOP is maintained at all phases of the manufacturing process. My client recognizes the need for a new QA Officer to expand their current existing team due to company growth over the past 12-month.

Currently based in Chippenham, easily commutable from major surrounding cities including Bath, Bristol and Chippenham are looking for a Full Time QA Officer to join their dynamic team specifically engaging with various team in and around GMP, ensuring the QMS aligns with current strategies.

Main Purpose of the Job:

Within this role, you will work to monitor the effectiveness of our QMS and ability of our suppliers to make product that aligns with our strategy. This can prove especially challenging when you consider the diverse nature of the product portfolio, ranging from sterile injectable medicines through to Lypsyl, a moisturising lip balm. Adapting our application of Quality, in such a diverse environment, requires flexibility, pragmatism and a willingness to engage.

Within the Quality department, you will have the opportunity to interact with disciplines such as Medical, Pharmacovigilance, Marketing & Commercial which brings additional challenges associated with the application of our QMS. As a Quality Officer, you will use you experience and knowledge to assess and interpret outputs from our QMS for impact on product to safeguard the consumer.

Key Responsibilities:

Support the QMS by: * Maintain, support and improve the QMS

  • Promote continuous improvement
  • Reviewing non-conformances & CAPA
  • Reviewing product quality investigations
  • Perform self-inspections in line with schedule
  • Support the product release process
  • Supports product quality complaint process
  • Supports external supplier audit and qualification
  • Support the CSV processes
  • Generating reports on the performance of the QMS against defined performance measures and key KPIs.
  • Maintenance of Supplier related schedules and review of documentation associated with e.g. Audits, PQRs, QTAs, etc.
  • Liaise with suppliers to ensure Quality Agreements & Product Quality Reviews are received and reviewed in line with the agreed schedule

Job requirements:

A degree or equivalent in a scientific discipline is preferred with experience in a Quality environment in a healthcare industry.

An understanding and knowledge of GMP, the legal and routine duties of various statutory roles (i.e. QP, RP, PRRC (for Medical Devices)) and the role of the various authorisation and registrations (i.e. marketing authorisations, technical files, product information files).

Desired:

  • 3 – 5 years’ experience in a relevant Quality Assurance role at a healthcare product manufacturer
  • A Quality Officer should be able to ensure all relevant aspects and possible repercussions are considered regarding these quality issues.
  • Ability to perform internal audits

Experience in associated standards and legislation, such as:

  • EUDRALEX Volume 4 – EU Good Manufacturing Practice
  • ISO 13485, 22719, 14971
  • 2001/83/EC, Dir. 93/42/EEC
  • Experienced in the use of Electronic QMS systems
  • Experience and understanding of computer systems validation and associate standards.
  • Experienced with quality assurance of cosmetics and food supplements
  • A Quality Officer should be able to ensure all relevant aspects and possible repercussions are considered regarding these quality issues.

If you would like to find out more about this opportunity please do not hesitate to apply for this role, I will be happy to discuss in further detail and get your CV submitted for this opportunity!

Expected salary:

Location: Chippenham, Wiltshire

Job date: Fri, 01 Oct 2021 07:48:48 GMT

Apply for the job now

Leave a Reply

Your email address will not be published. Required fields are marked *

Translate ยป
Skip to content