Hours: Mon – Fri (8.30am - 5.00pm)
Type: Permanent
About the role
Due to the significant expansion of the company. 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.
Duties
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
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
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,
Write, review and update SOP’s and documentation relating to job role.
Responsible for the management and closure of Deviations, CAPA, Change Controls and
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.
Requirements
Excellent working knowledge of current GMP requirements.
QA experience.
Excellent communication and management skills.