This is an opportunity to work for an up and coming expanding API manufacturer. BSPG Laboratories Ltd specialises in the supply of industrial hemp derivatives for medical and nutraceutical markets, specifically CBD. Based in our facility at the Discovery Park Science Park you will be able to enjoy a professional working environment and the facilities it has to offer.

About the role:

Due to the significant expansion of BSPG Laboratories Ltd. we are now recruiting for a Senior Quality Assurance (QA) Officer to join and support our team. If successful, you will be joining a team of motivated and self-driven individuals with a passion for ensuring the success of this exciting project.

Previous quality experience is necessary.

The main responsibilities of the role will be but are not limited to:

· Strict adherence to GMP.

· Develop right first-time documentation and strategies

· Develop and oversee validation activities for both the current and new facility (including protocols and reports).

· Lead self-inspection audits.

· Manage all process deviations and planned process changes.

· Check and authorise all completed process documentation.

· Develop and periodically review the Validation Master Plan (VMP) alongside the QA Manager.

· Undertake external audits.

· Develop Quality databases including metrics.

· Manage product recalls alongside the QA Manager.

· Ensure Quality agreements are in place to cover business relationships.

· Generate NDA’s and Technical Agreements with any 3rd parties.

· Liaise with collaborators, contracts and customers as required.

· Oversee and manage QMS changes.

· Document coordination to ensure all SOP’s, policies and other such documents are created, formatted and stored correctly according to company procedures.

· Write, review and update SOP’s and documentation relating to job role.

· Responsible for the management and closure of Deviations, CAPA, Change Controls and OOS/OOT’s, alongside the QA Manager.

· Training new members of staff within the QA department.

· Operate independently in ambiguous situation.

· Make day-to-day decisions and apply timely risk-based decision making under minimal supervision.

· Detailed understanding and interpretation of the GMP, quality systems and GMP processes for the R&D environment.

· Responsible for the Technical Review and Release of batches in the absence of the QA Manager.

· Ability to find solutions when issues may arise within the manufacturing and Quality Control units.

The successful candidate:

· Ability to write concisely in plain English

· Ability to apply a pragmatic approach to work

· Critical thinker

· A willingness to learn

· Educated

· Excellent working knowledge of current GMP requirements

· Excellent communication and management skills

· Ability to prioritise workload in order to meet commitments

· Respect for confidentiality

· Proactive and enthusiastic

· Attention to detail

· Logical and methodical approach

· Previous audit experience

· Computer literate

· Flexible in relation to hours of work

What we offer:

21 Days paid holiday plus bank holidays
Company Pension Scheme
Modern comfortable office environment

Free Parking
Access to on site gym and Cafeteria
Death in Service Benefit

Access to cycle to work scheme

On successful completion of a probationary period:

Private Healthcare
Opportunities for growth and progression

Closing date for applications is Monday the 8th August 2022.