Medreich plc
Location: Feltham, TW13 7HF
Quality Assurance Officer
Medreich is an established pharmaceutical company based in Feltham. Medreich Plc pride ourselves on being an employer who is passionate about our employees and their development and wellbeing.
Job Role
The Quality Assurance Officer shall support Quality Management System (QMS) activities and ensure compliance with applicable GMP requirements. The role involves handling deviations, change controls, complaints, batch release documentation review, and coordination with internal and external stakeholders to maintain compliance and product quality standards.
Key Responsibilities:
Quality Management System (QMS)
Knowledge on Change Controls, Deviations, CAPAs, and Product Quality Complaints.
Participate in investigations and follow-up of quality events.
Track QMS activities to ensure timely closure and compliance with defined timelines.
Support preparation of quality metrics and trend reports.
Batch Release Activities:
Support QPs for batch release activities in accordance with approved procedures.
Documentation and Compliance:
Prepare SOPs (Standard Operating Procedures), protocols, reports, and quality documents.
Ensure GMP documentation practices are followed.
Support internal audits, self-inspections, and regulatory inspection readiness activities.
Communication and Coordination:
Coordinate with Manufacturing, QC, Regulatory Affairs, Supply Chain, and Contract Manufacturing Organizations (CMOs).
Follow up on quality-related actions and provide timely updates to stakeholders.
Required Knowledge:
Basic knowledge of GMP requirements (EU GMP, WHO GMP, PIC/S, or US FDA regulations).
Understanding of Change Control, Deviation Management, CAPA, Complaints Handling, and Batch Release processes.
Knowledge of Good Documentation Practices (GDP) and Data Integrity principles.
Skills and Competencies:
Excellent verbal and written communication skills.
English language proficiency (speaking, reading, and writing).
Strong attention to detail and documentation review skills.
Ability to work independently and within cross-functional teams.
Excellent organisational and time management skills.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
Wide knowledge of products and processes used in the manufacture of medicines.
Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
The right candidate will also have:
- 2-3 years of working knowledge within a QA role in the pharmaceutical industry.
- An enthusiastic, confident, and self-motivated personality and the ability to quickly contribute to the culture and way of working.
- Computer literate and numerate.
- Ability to work in a team environment.
- Ability to work under pressure and meet deadlines.
- Able to work in autonomy and demonstrate engagement and ability to use initiative.
- Able to share experience and good practices with team members.
- Observing and complying with company SOP's & Health and Safety Policies.
- Contribute to any other related tasks as and when required
Salary & Benefits
· Salary £32,000-£35,000 depending on experience.
· Annual bonus (non-contractual, subject to company and individual performance)
· Pension scheme (up to 10% employer contribution)
· Life insurance
· 25 days annual leave
· Cycle to work Scheme
· Free parking on Site
· Flexible hours to be agreed with Line Manager
· One day working from home per week on completion of successful probation period.
Job Type: Full-time
Pay: £32,000.00-£35,000.00 per year
Benefits:
- Casual dress
- Company pension
- Cycle to work scheme
- Flexitime
- Free parking
- Life insurance
- On-site parking
Ability to commute/relocate:
- Feltham TW13: reliably commute or plan to relocate before starting work (required)
Application question(s):
- Have you worked in the pharmaceutical industry?
Education:
Experience:
Language:
Work authorisation:
- United Kingdom (required)
Work Location: In person
