Quality Assurance Specialist

**In your role you will**:

- Foster and promote Quality Compliance (GMP) within the site and comply with company policies.
- Review Finished Batch Record and GMP Release for final QP Release
- Support ongoing preparation for Regulatory Licence approvals
- Oversee and input to QMS related Change Control, Non-conformance and CAPA activities
- Develop, Enhance and update the Quality Management System activities associated with the release of product, integrating as appropriate into central activities.
- Ensure appropriate maintenance of filing of Quality related documents, including Deviations and CAPA’s.
- Maintain all QA databases which include but are not limited to QMS, master list, quality metrics, errors, daily orders, product enquiries and documents.
- Support in product enquiries ensuring timely responses.
- Control and maintenance of Quality documentation, including generating, reviewing, issuing SOPs, forms and BMRs.
- Liaise with suppliers in order to obtain documents needed for Quality Approval such as leaflets, cartons and licences.
- Documentation writing including reports, recording deviations, non-compliances and other quality related forms.

**Day to day tasks**
- Coordinate and manage to resolve customer complaints, recalls, change controls etc. ensuring proper root cause analysis and prompt responses/resolution.
- Collate data on aspects of the quality management system for incorporation into regular periodic reports.
- Reporting all deviations, complaints, change control and errors to seniors and QA Manager and carrying out quality investigations and QA closure.
- Support internal and external audits/inspection.
- Taking part in the internal audit programme to ensure continued GMP compliance of all site activities.
- Liaise with all departments to improve operations, quality of service and develop a positive progressive culture.
- Participate in training activities and maintain personal training records in an auditable state.
- Endeavour to constantly increase your skill set and participate in overall quality functions.
- Undertake any task, duties and responsibilities required by your Line manager with appropriate instruction and training.
- Working closely with the line manager to ensure compliance to GMP and procedures.
- All assigned tasks completed in a timely manner.
- Assigned databases and quality metrics must be in an inspection ready state always.
- Liaising with all departments to follow up on actions and documents under review.
- Close working within QA and other departments at Eaststone to ensure that all teams adhere to the Quality framework and guidelines.
- Customer Focus
- Personal Integrity
- Drive and resilience
- Team working
- Developing self and others

**REQUIRED QUALIFICATIONS**: Scientific Degree (Preferably in a pharmaceutical or chemistry discipline). **YOU WILL NOT BE CONTACTED WITHOUT THIS QUALIFICATION.**

**You will also have the following skills**:

- Excellent team, interpersonal skills, and communication skills.
- Excellent organisational and time management skills.
- Ability to work successfully as part of a team or using own initiative, sharing knowledge, collaborating with and supporting colleagues.
- Motivated, results and delivery focused with a commitment to quality of work.
- Takes ownership and actively looks for personal learning and development opportunities.
- Flexible in approach and adaptable to change.
- Proficient in Word, Excel, PowerPoint.

**With Experience in the following areas**:

- Product release experience in a pharmaceutical background is ideal.
- Understanding of Regulatory Affairs and GMP compliance guidelines.
- Good problem management skills - focus on finding the right solutions and problem solving