Quality Assurance Specialist

Job Description

The right candidate will have be responsible for administration and database control within the department. The focus will be to provide administrative support to customers and colleagues. You will be responsible for maintaining databases such as error recording,enquiries, final release, CAPA and QMS. The scope will also include overseeing the quality of all products manufactured or sourced by the company and ensure adherence to GMP, GDP, documented procedures and work instructions.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 CAPAs.
• 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.

The right candidate will be:

• 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

If you would like a further conversation regarding this role please apply through this site, and one of our colleagues will get back to you.

Keyskills :
CAPAInspectionInternal AuditQuality Management