Quality Assurance Officer
37.5hrs per week
Monday - Friday
Company Details
Walkboost Group was established in 2003 and consists of 3 Pharmaceutical companies; all of the companies are based in Bolton. In total Walkboost Group has c150 staff. Maxearn Ltd is a parallel import company; Quadrant Limited is a licensing company and Eaststone Ltd is a Specials (unlicensed medicines) manufacturing company.
Job Description
To oversee the quality of all products manufactured or sourced by Eaststone Limited, ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and applicable regulatory requirements.
The role is responsible for supporting and maintaining the Quality Management System (QMS) whilst also performing operational Quality Assurance activities, ensuring quality compliance across manufacturing, distribution, customer services, controlled drugs management.
The post holder will provide support to the wider Quality Department and Eaststone as required, ensuring quality systems remain compliant, effective, and continuously improved.
Daily Activities
Quality Management System (QMS)
- Maintain and continuously improve the Quality Management System.
- Generate, review, approve, and update SOPs, forms, specifications, and other quality documentation.
- Execute and maintain quality system processes
- Review QC, R&D, Production, Customer Service and Dispatch QMS documentation.
- Support the generation of Quality Metrics and KPI reports.
- Maintain site-wide training records and training matrix.
- Maintain quality documentation and archiving systems.
- Participate in quality improvement initiatives and continuous improvement projects.
Operational Quality Assurance
- To be trained and deemed competent to provide Batch Manufacturing Records (BMR) generation cover during periods of absence of the designated BMR Generator.
- Provide technical assistance and support to manufacturing operations when required.
- To perform all tasks highlighted on the QA task board
- Support temperature mapping and temperature monitoring activities across the site.
- Monitor and maintain temperature monitoring systems for equipment and controlled areas.
Investigations, Complaints & Customer Support
- Provide support to customers by responding to quality, technical, and product-related queries.
- Coordinate and investigate customer complaints, ensuring timely resolution and closure.
- Support product investigations and root cause analysis activities.
- Respond to internal and external medicines information requests.
Auditing & Regulatory Compliance
- Participate in the internal audit programme.
- Support and execute supplier, customer, and external audits.
- Support management during regulatory inspections and audits.
- Ensure ongoing compliance with GMP, GDP, and Controlled Drugs regulations in line with MHRA and the Home Office.
Supplier, Outsourced Activity Provider (OAP) & Customer Quality Agreement Management
- Support the approval and ongoing management of suppliers OAPs and customers.
- Assist in the generation, review, and maintenance of Technical Quality Agreements.
- Support qualification and monitoring activities relating to suppliers, OAPs and customers.
- Support the management and oversight of couriers used by Eaststone.
Controlled Drugs Compliance
- Support importation and exportation activities relating to controlled drugs
- Support controlled drug management, reconciliation, and destruction activities.
- Perform annual controlled drug returns as required.
- Ensure compliance with applicable Home Office and MHRA requirements relating to controlled drugs.
General Responsibilities
- Utilise scientific and technical resources to improve product quality and service delivery.
- Maintain personal training records in an audit-ready state.
- Undertake any reasonable task requested by the QA Leads, QA Manager or Head of Quality/RP for which appropriate training and instruction have been provided.
- Work collaboratively across departments to support business objectives and regulatory compliance.
- Promote a culture of quality, compliance, and continuous improvement.
Essential Experience & Qualifications
- Educated to Degree Level in a scientific, pharmaceutical, or related discipline (preferred).
- Alternative qualifications and relevant industry experience may be considered.
- Knowledge of GMP and GDP requirements within pharmaceutical manufacturing and distribution.
- IT skills, including Microsoft Word and Excel.
- Willingness to work flexible hours
Desirable
- 2 years' GMP experience within a pharmaceutical environment.
- Experience working with Quality Management Systems.
- Experience with controlled drugs and/or Cannabis-Based Products for Medicinal Use (CBPMs).
- Experience supporting regulatory inspections and audits.
- Demonstrated compliance with procedures, policies, and regulatory requirements.
Other Requirements
- Excellent written and verbal communication skills.
- Strong organisational and time management skills.
- Excellent attention to detail.
- Ability to analyse problems and implement effective solutions.
- Ability to work independently and as part of a team.
- Good interpersonal skills and ability to work effectively with multicultural teams.
- Safe adoption of working practises together with an understanding of the needs for precise and accurate documentation
- Ability to work to strict deadlines and manage multiple priorities.
- Ability to assume responsibility and act on own initiative where required
- Motivated, accurate, discreet, and professional in approach.
- Adaptable with a proactive, hands-on attitude.
Pay: From £27,000.00 per year
Benefits:
- Additional leave
- Company pension
- Free parking
- Health & wellbeing programme
- Referral programme
- Sick pay
Work Location: In person
