QMS Officer – Production
Location: Weedon Bec, Northampton, NN7
Department: Production
Reporting to: Head of Production
Job Type: Full-time, Permanent
Work Location: On-site
About LM Manufacturing Limited
LM Manufacturing Limited is a pharmaceutical manufacturer based in Weedon Bec, Northampton and part of the Zydus Group, a global pharmaceutical organisation committed to quality, innovation and patient care.
Our MHRA and FDA-approved manufacturing facility operates to high standards of Good Manufacturing Practice (GMP), quality and regulatory compliance.
As part of our continued growth, we are looking for an experienced QMS Officer – Production to join our team.
About the Role
Reporting to the Head of Production, the QMS Officer will support the effective management and coordination of Quality Management System (QMS) activities within Production.
The role will have hands-on responsibility for investigations, deviations, CAPAs, change controls, SOPs, risk assessments, training coordination and production documentation, ensuring activities are completed accurately and within required timelines.
Key Responsibilities
- Prepare, review, initiate, follow up and support the timely closure of investigations, including OOS, OOT, OOE, deviations and market complaints.
- Prepare, review, initiate, track and support the closure of change controls.
- Prepare, review, initiate, monitor and support the closure of CAPAs.
- Prepare and review risk assessments and protocols.
- Prepare, review, initiate and maintain Standard Operating Procedures (SOPs).
- Coordinate Production QMS activities and ensure actions are appropriately tracked and escalated.
- Monitor QMS timelines and proactively follow up with relevant stakeholders to ensure timely completion and closure.
- Support site training coordination activities, including training initiation, review, closure and maintenance of appropriate training records.
- Ensure cGMP documentation is maintained in accordance with company procedures and the Quality Management System.
- Review Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
- Review Production QMS documentation, records and logbooks.
- Identify and report non-conformances to the Head of Production and relevant Quality personnel.
- Work closely with Production, QA and other cross-functional teams to support investigations and QMS activities.
- Participate in internal and external training programmes.
- Maintain GMP compliance within the working area, including adherence to approved procedures, gowning requirements and site practices.
- Support continuous improvement activities within Production.
- Perform other duties and responsibilities appropriate to the role as assigned by management.
- Comply with all company Health & Safety, Quality and GMP requirements.
Essential Skills & Experience
- Relevant experience within the pharmaceutical industry, ideally within Production, Quality Assurance or a QMS-focused role.
- Practical working knowledge of pharmaceutical Quality Management Systems.
- Hands-on experience with deviations, investigations, CAPA and change control.
- Good understanding of cGMP and Good Documentation Practice (GDP).
- Experience preparing and reviewing SOPs and controlled documentation.
- Ability to investigate issues, identify root causes and support appropriate corrective and preventive actions.
- Strong attention to detail with a quality and compliance-focused approach.
- Ability to take ownership and responsibility for assigned activities and drive them through to completion.
- Ability to work independently and collaboratively within a cross-functional team.
- Strong organisational and time-management skills with the ability to manage multiple QMS activities and deadlines.
- Good written and verbal communication skills.
- Proficient in Microsoft Office applications.
- Self-motivated, proactive and able to work effectively within a fast-paced pharmaceutical manufacturing environment.
Desirable
- Experience within an MHRA and/or FDA-regulated pharmaceutical manufacturing environment.
- Experience reviewing BMRs/BPRs and production documentation.
- Experience with root cause analysis and investigation methodologies.
- Experience coordinating or maintaining GMP training records.
Why Join LM Manufacturing Limited?
This is an opportunity to join a growing pharmaceutical manufacturing organisation and work closely with Production and Quality teams in a regulated manufacturing environment.
We provide opportunities for training, professional development and career progression as the organisation continues to grow.
LM Manufacturing Limited is an equal opportunities employer. We welcome applications from suitably qualified candidates and are committed to providing an inclusive working environment.
Job Type: Full-time, Permanent
Work Location: In person – Weedon Bec, Northampton, NN7
Pay: £27,000.00-£30,000.00 per year
Benefits:
Application question(s):
- Do you have relevant experience working in a pharmaceutical manufacturing environment in a QMS, Production Quality or Quality Assurance role?
Work authorisation:
- United Kingdom (required)
Work Location: In person
