Quality Officer - Rowlands Gill, United Kingdom - Quantum Pharmaceutical

Quantum Pharmaceutical

Verified Company

Rowlands Gill, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Our Quality Assurance department are key to making sure the products we make and distribute are of the highest standard and that all our departments are working in compliance with Good Manufacturing Practices.

As a Quality Officer - Validation your responsibilities will include, though will not be limited to:

Acting as the Quality representative on validation teams.
Assisting the Validation Manager with the Site Validation Master Plan (SVMP) activities to ensure continual compliance, by working with multidisciplinary teams across site.
Ensuring that the manufacturing facilities (aseptic and nonsterile), process, equipment and computer systems are validated in full compliance with GMP, GDP and regulatory requirements to meet the stipulated product quality, patient safety & data integrity standards in line with established specifications or requirements of the organisation.
Assisting with the introduction of new equipment, processes, and systems through the creation of technical documentation including, but not limited to VP, URS, IQ, OQ and PQ.
Ensuring all stages of the validation lifecycle, Annex 11 and Annex 15 are met with new and existing equipment, processes, and computer systems.
Working closely with the Validation Manager and Operations to develop and maintain a Cleaning Validation/Verification package for all product contact equipment and manage the 'live' cleaning validation matrix.
Acting as final Quality reviewer of validation documents or, when applicable, be the author of validation documents.
Supporting the operational teams on existing and future validation projects.
Ensuring that all validation projects are performed in line with the documentation requirements of the validation system, including quality risk management principles.
Assisting with training in validation procedures.
Providing consistent validation advice to key stakeholders.
Producing data and report on performance, measuring against set key performance indicator.
Ensuring regulatory changes which have an impact to validation are appropriately assessed for their impact on the business.
Deputising for the Validation Manager, when required
Writing, reviewing, and approving quality documents.
Supporting all departments with quality activities such as the raising and execution of quality documents.
Leading, participating in, and reviewing all types of investigations, Root Cause Analysis and Quality Risk Management.
Participating, where applicable, in any audits of potential and current vendors.
Leading and supporting internal audits.
Assisting with the preparation and execution of regulatory and customer audits.

As with all Group employees, you'll also be asked to:

Ensure the work you do is of a high standard and that Group procedures and policies are followed.
Act as an ambassador for the business, presenting the Group in a positive way with clients, customers, and colleagues.
Work flexibly and efficiently to meet customer needs, whilst maintaining the highest possible professional standards.
Always maintain confidentiality and security.

To be successful in this role, you should be able to demonstrate:

Hands on knowledge and experience of preparing and executing validation documentation
A supportive nature and good teamplaying mentality
Being capable of working towards KPIs
Excellent communication skills
The ability to work at pace and in a highpressured environment

**Many shift patterns are available, between our core hours of 0500 and 2200.