Quality Assurance Administrator

Job Title: Quality Assurance Administrator

Reports To: Quality Manager

Location: Livingston, Scotland

Salary: £26,250 – £28,000 per annum FTE, depending on experience

Hours: Flexible – full\-time or part\-time hours considered

About The Role

This is an exciting opportunity for an organised and detail\-focused Quality Assurance Administrator to join our Quality team in Livingston.

The role will provide administrative and documentation support across Tepnel’s Quality Management System (QMS), helping to ensure that quality records, controlled documents, training records and associated systems are maintained accurately and efficiently.

Previous experience within a pharmaceutical, GMP or other regulated environment would be beneficial; however, GMP experience is not an absolute requirement. We are equally interested in candidates with strong administrative skills, excellent attention to detail and the ability and willingness to learn within a regulated environment.

We recognise that flexibility is important and are therefore open to discussing flexible working hours, including both full\-time and part\-time arrangements.

Responsibilities

Main responsibilities will include:

• Providing day\-to\-day administrative support to the Quality Department.


• Supporting the administration and maintenance of the Quality Management System (QMS).


• Assisting with the preparation, formatting, issue, distribution and archiving of controlled documents, including SOPs, forms and associated quality documentation.


• Maintaining accurate electronic and paper\-based quality records.


• Supporting the administration of non\-conformances, CAPAs, change controls, complaints, audits and other quality records.


• Monitoring quality records and assisting with the tracking of actions, due dates and overdue items.


• Supporting the administration and maintenance of employee training records.


• Assisting with document control activities, including document distribution, retrieval, reconciliation and archiving.


• Supporting the preparation and collation of documentation for internal audits, customer audits and regulatory inspections.


• Assisting with the preparation of Quality metrics, reports and routine departmental information.


• Liaising with colleagues across the business to obtain information and documentation required to progress Quality activities.


• Supporting general Quality Department organisation and administration.


• Ensuring confidential and sensitive information is handled appropriately.


• Performing other reasonable administrative duties in support of the Quality function.

In general, the postholder will ensure that all work undertaken meets the requirements of the Tepnel Quality System and, following appropriate training, applicable cGMP requirements.

About You

You will be a highly organised individual with strong attention to detail and an interest in working within a Quality and regulated environment.

Ideally, you will have:

• Previous experience in an administrative, document control or Quality support role.


• Excellent organisational and time\-management skills.


• Strong attention to detail and a methodical approach to work.


• Good written and verbal communication skills.


• Confidence working with electronic systems and Microsoft Office applications.


• The ability to manage multiple activities and changing priorities.


• The ability to work independently while also contributing effectively as part of a team.


• A professional approach to confidential and sensitive information.


• A willingness to learn new systems, processes and regulatory requirements.


• A proactive and positive approach to supporting colleagues across the business.

Experience of the following would be advantageous, but is not essential:

• Working within a GMP\-regulated pharmaceutical, biotechnology or laboratory environment.


• Working within another regulated environment where accurate documentation and record keeping are important.


• Quality Management Systems (QMS).


• Electronic document management or Quality systems.


• Document control.


• Training administration.


• CAPA, non\-conformance, change control or audit administration.

Full training will be provided on Tepnel's Quality Management System and applicable GMP requirements.

What You’ll Do

You will play an important role in supporting the effective operation of the Quality Department and ensuring that Quality documentation and records are maintained to a consistently high standard.

You will work closely with the Quality Manager and colleagues throughout the business to help ensure that records are progressed, documentation remains current and Quality activities are appropriately tracked and administered.

The role will include:

• Maintaining accurate and well\-organised Quality documentation.


• Supporting the timely progression and closure of Quality records.


• Helping ensure controlled documents are issued, maintained and archived correctly.


• Supporting training record administration and associated documentation.


• Maintaining trackers and providing visibility of outstanding Quality activities.


• Supporting audit and regulatory inspection preparation.


• Assisting the Quality team with routine reporting and Quality metrics.


• Identifying administrative issues or missing information and escalating these appropriately.


• Working with a Right\-First\-Time mentality and maintaining a high standard of accuracy.


• Observing and complying with Good Manufacturing Practice (GMP), following appropriate training.


• Observing and complying with company policies, procedures and Health \& Safety requirements.

The role is primarily administrative and supportive in nature. Responsibility for Quality decisions, investigation approval, batch disposition and other activities requiring designated Quality authority will remain with appropriately trained and authorised personnel.

Your Background

You do not necessarily need previous pharmaceutical experience to be successful in this role.

We are looking for someone who is organised, accurate, dependable and comfortable working with documentation and computer\-based systems. Previous administrative experience would be beneficial, particularly where accuracy, record keeping, document control or compliance have been important.

Experience within pharmaceutical, laboratory or GMP Quality Assurance would be advantageous and may support appointment towards the upper end of the salary range, but we are equally willing to consider an individual with strong transferable administrative skills who demonstrates the right aptitude and willingness to learn.

Above all, you will have excellent attention to detail, good communication skills and a quality\-focused approach to your work.

Pay: £26,250\.00\-£28,000\.00 per year

Work Location: In person

This listing is from Indeed. View original listing ↗