Quality Assurance Officer

Location
Bradford
Salary
Dependent on experience.
Posted
22 Aug 2019
Closes
19 Sep 2019
Ref
J5632095
Contact
Jessica McLachlan
Contract Type
Permanent
Hours
Full Time
We are currently supporting a key client of ours in their search for a Quality Assurance Officer to join their facility based in the West Yorkshire area. The company are a growing life sciences firm and in order to enhance their current client services, they are developing their existing analytical laboratories in West Yorkshire.

Your role as the Quality Assurance Officer will focus on the independent cGMP review and approval of work conducted at the facility including analytical method development, method verification/validation, release testing and stability studies for clients in the pharmaceutical, healthcare and medical device industries. The role will also include working with the team of Scientists on site to implement, maintain and improve procedures and processes that support GMP compliance. This role will additionally provide the opportunity to cross-train in GLP auditing.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Quality Assurance Officer will be varied however the key duties and responsibilities are as follows:

1. Undertake routine checking, review and approval of cGMP laboratory reports, data summaries, COAs, performance verifications, validation and method transfer protocols, in addition to routine review of laboratory and project notebooks.

2. Provide assistance in support of Change Controls, Equipment Qualification, Non-Conformances, OOS/OOT and Exception Reports. Additionally, you will hold control of the site archiving facility and be responsible for archiving and retrieval of records.

3. Develop and review QA-related SOPs, policies and pro-formas, and maintain the associated database of quality documentation.

4. Schedule and perform external and internal audits and inspections as assigned, reporting any deficiencies to the Quality Manager and site management. Generate audit reports and follow-up actions.

5. Train other personnel in all aspects of QA systems and procedures as required.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Quality Assurance Officer we are looking to identify the following on your profile and past history:

1. Relevant degree in a analytical, chemical or related scientific discipline.

2. Proven industry experience in a cGMP analytical environment or with Regulatory GLP, including GLP auditing, ideally within pharmaceutical manufacturing.

Key Words: QA | quality assurance | QC | quality control | GMP | manufacturing | cGMP | GLP | cGLP | audit | pharmaceuticals | API | medical device | healthcare

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