Quality Assurance Officer

Quality Assurance Officer

X12 month Fixed Term Contract

Monday - Thursday 7.30am - 4.00pm

Friday 7.30 - 2.00pm

37.5 hours (Variable)

My client is a large manufacturing business, developing and producing Cosmetic, Nutritional, Pharma and Medical Device markets from three production sites and one logistics centre in the UK.

About the role:

Reporting to the Quality Assurance Supervisor, this post is responsible for the review and control of all technical documentation relating to medicinal and medical device packed products.

The post will also cover other aspects of documentation control within our Quality Management system.

This is a varied, hands-on, office-based role in a fast-paced environment, which requires flexibility, enthusiasm, accuracy and attention to detail at all times. The post holder will require strong administration skills with a good level of literacy.

The post holder will be required to liaise with personnel at a variety of different levels including other departments and customers.

Job Description

Key Duties and Responsibilities:

• Maintenance of the company Quality Management System (QMS) in compliance with ISO 13485 and any regulatory and/or customer requirements.

• Liaison with all departments via Q Pulse to ensure implemented SOPs are maintained and formally reviewed at least every two years.

• SME for Document Module in Q Pulse with responsibility for training where required

• Control of Quality documents within Q Pulse

• Medicinal batch review for Qualified Person (QP) batch release.

• Distribution of medicinal paperwork / to customers as required

• Archiving medicinal/ medical device batch documentation

• Medical device batch documentation review and release

• Distribution of medicinal paperwork / to customers as required

• Ensure the creation of Product Quality Review (PQR) documentation is completed to set schedule

• Carry out any other reasonable duties at the request of the Quality Assurance Supervisor, Quality Manager, Quality Director or Qualified Persons.

Skills/Experience required:

• Strong administration skills and good attention to detail- essential

• Ability to handle multiple demands to be self-managing and to work under pressure- essential

• Ability to gain respect and credibility within the team, through demonstration of technical knowledge and transferable skills- essential

• Good knowledge of Microsoft Office gained through practical experience- essential

• Experienced technically minded administrator familiar with maintaining a Quality Management System- desired

• Educated to degree level qualification or equivalent- desired

• Experience of working within a production, ideally packaging, environment- desired

• Ability to manage a team, provide support and develop team members in line with company values

Personal Attributes:

• Ability to build strong relationships with internal and external customers, suppliers and regulatory bodies.

• A confident individual able to communicate effectively with all levels of personnel.

• Demonstrate ability to efficiently plan, organise and manage own workload.

• Ability to prioritise workload of others.

• Good verbal communication and interpersonal skills