About the job

Pharmaceutical Manufacturing | Full-Time | Permanent

Our client, a well-established pharmaceutical manufacturer, is looking for a meticulous and dedicated QA Officer to join their Quality Assurance team. This is a genuinely important role: one where your attention to detail directly protects patient safety and product excellence, and where no two days look quite the same.

The RoleAs QA Officer, you'll act as the go-to Quality Assurance representative across campaign and change projects — reviewing, checking and signing off the details that keep manufacturing compliant, safe and audit-ready. You'll be trusted to spot issues before they become problems, escalate what matters, and help drive a genuine culture of quality across the site.

• What You'll Be DoingCarrying out routine QA checks on manufacturing processes, raw materials, in-process materials and finished products against SOPs and regulatory guidelines (GMP/GLP).
• Conducting internal audits and supporting external audits, including regulatory inspections and customer visits.
• Reviewing and approving batch manufacturing records, packaging records and laboratory data for accuracy and compliance.
• Investigating deviations, non-conformances and out-of-specification results — getting to the real root cause and proposing effective CAPAs.
• Owning and maintaining Quality Management System documentation: SOPs, protocols and reports.
• Contributing to change control, risk assessments and product quality reviews.
• Supporting training on quality systems and good manufacturing practice.
• Working closely with Production, QC and R&D to resolve quality issues collaboratively.
• Preparing quality trend reports and sharing findings with management.
• Keeping compliance front and centre with relevant national and international pharmaceutical regulations.

• What You'll BringA degree in a related scientific field.
• At least 2 years' experience in a Quality Assurance role within pharmaceuticals or another closely regulated industry.
• Solid working knowledge of GMP regulations — MHRA and FDA experience is a strong plus.
• Hands-on experience with Quality Management Systems and documentation control.
• A sharp analytical mind, comfortable with root cause analysis and CAPA implementation.
• Excellent attention to detail and strong organisational skills.
• Clear, confident written and verbal communication — you can explain a complex quality issue so anyone can follow it.
• Good working knowledge of Microsoft Office (Word, Excel, PowerPoint).
• The ability to work independently and as part of a team, in a fast-paced environment.
• An understanding of the pharmaceutical product lifecycle and quality risk management principles.

Why This Role

You'll be joining a team that treats quality as a shared responsibility, not a box-ticking exercise — where your judgement is trusted, your voice is heard, and your work has a direct line to patient safety. If you're looking for a role with real substance and the chance to make a tangible difference, this is it.

Interested? Apply now to find out more about this opportunity.

About the job

Position Summary

The QA Specialist provides Quality Assurance support for Investigational Medicinal Product (IMP) manufacturing and associated Quality Management Systems at MedPharm.

The role is responsible for supporting compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), applicable regulatory requirements and internal quality procedures through the review of quality documentation, management of quality systems and QA oversight of manufacturing and laboratory activities.

The QA Specialist works closely with Production, Quality Control, Pharmaceutical Development and other departments to ensure quality systems remain effective, regulatory expectations are met, and products are manufactured and released in compliance with applicable legislation and client requirements.

Essential Functions

• Quality Management System
  • Raise, review and manage Quality Management System (QMS) records including deviations, change controls, CAPAs, investigations, complaints and quality risk assessments.
  • Support timely progression and closure of quality records in accordance with internal procedures.
  • Ensure quality records are complete, scientifically justified and compliant with regulatory expectations.
  • Support continuous improvement of Quality Management System processes.
• Documentation Control
  • Review and approve controlled documents including SOPs, forms, protocols, reports, specifications and quality records within the electronic Quality Management System (eQMS).
  • Ensure documentation complies with Good Documentation Practice (GDP) and ALCOA+ data integrity principles.
  • Maintain document control processes including document issuance, revision, archival and retention.
  • Support management of controlled templates and quality documentation.
• Manufacturing QA Oversight
  • Perform QA review of Batch Manufacturing Records (BMRs) before manufacture where applicable.
  • Review completed manufacturing documentation for completeness, accuracy and compliance prior to QP certification.
  • Provide QA support during manufacturing activities as required.
  • Support review of manufacturing investigations and manufacturing deviations.
  • Escalate quality concerns where product quality or patient safety may be impacted.
• Laboratory QA Support
  • Review Quality Control documentation including specifications, analytical methods, sampling instructions and protocols.
  • Support review of analytical investigations including OOS, OOT and atypical results.
  • Review laboratory documentation to ensure compliance with GMP, GLP and internal procedures.
  • Support QA oversight of reference standards, retained samples and stability documentation where applicable.
• Materials Management
  • Perform QA review and disposition of starting materials, packaging materials and finished products in accordance with approved procedures and delegated QA authority.
  • Support supplier qualification activities including supplier assessments, audits and technical agreements.
  • Support ongoing supplier performance monitoring.
• Audits and Inspections
  • Participate in internal self-inspections and supplier audits.
  • Support preparation for customer audits and regulatory inspections.
  • Assist with implementation and follow-up of audit observations and CAPAs.
  • Support inspection readiness activities across the site
• Data Integrity
  • Ensure quality documentation and electronic records comply with applicable data integrity requirements.
  • Promote Good Documentation Practice throughout the organisation.
  • Identify and escalate potential data integrity concerns.
• Training
  • Support implementation of Quality Assurance procedures across the organisation.
  • Deliver or assist with GMP and Quality training where required.
  • Support maintenance of QA training records.
• Archiving
  • Act as GLP Archivist where applicable.
  • Coordinate archiving activities in accordance with company procedures and regulatory requirements.
  • Ensure records are retained and retrieved in accordance with approved retention schedules.
• Continuous Improvement
  • Identify opportunities to improve Quality Systems and regulatory compliance.
  • Participate in quality improvement projects.
  • Support implementation of new quality processes and systems.
  • Support quality metric reporting and trend analysis.
• General
  • Build effective working relationships with internal departments, clients and external service providers.
  • Maintain current knowledge of applicable GMP, GCP, GLP and regulatory requirements.
  • Perform other duties appropriate to the position as requested by QA Management
• Key RelationshipsHeads of Departments
• Senior Management
• Production
• Pharmaceutical Development
• Quality Control
• External Contractors (including specialists)
• Vendors/Suppliers
• Qualified Persons
• Contract Laboratories

Travel requirements:

None

• Education and ExperienceBachelor’s or Master’s degree in a scientific discipline (e.g., Pharmaceutical Sciences, Chemistry, Biology, or related field) or equivalent industry experience desirable but not essential.
• Minimum 2 years’ experience in a GMP-regulated pharmaceutical or biotechnology environment, preferably supporting IMP manufacturing or clinical trial supply.
• Demonstrated experience working within a Quality Management System (QMS) including deviations, CAPAs, change controls, investigations and audit responses..
• Experience reviewing batch manufacturing records (BMRs), manufacturing documentation and quality data to support batch release and QP certification.
• Experience supporting regulatory inspections, client audits and internal audits in a GMP environment.
• Knowledge, Skills, and AbilitiesStrong working knowledge of GMP, GCP and GLP regulations, with good understanding of EU GMP requirements and clinical trial manufacturing expectations.
• In-depth understanding of Quality Management Systems, including deviation investigations, CAPA management, change control and risk management processes.
• Strong experience reviewing manufacturing and quality documentation, including batch records, specifications, protocols and reports.
• Demonstrated ability to lead or support complex deviation investigations and root cause analysis activities.
• Good understanding of data integrity principles (ALCOA+) and regulatory expectations for documentation and electronic systems.
• Experience supporting audit readiness and inspection preparation within regulated pharmaceutical environments.
• Ability to provide technical QA oversight and guidance to cross-functional teams including Production, QC and R&D.
• Familiarity with electronic Quality Management Systems (eQMS) such as Master Control or similar platforms.
• Strong written and verbal communication skills with the ability to communicate quality requirements across departments.
• Ability to prioritise multiple quality activities and work effectively in a fast-paced regulated environment
• Demonstrated ability to mentor and support the development of junior QA personnel.
• Personal Attributes Highly organised
• Effective communicator able to translate technical concepts to non-technical users.
• Strong project management and change control skills.
• Able to influence and drive adoption of new systems across multidisciplinary teams

Physical Demands and Work Environment

• While performing the duties of this job, there may be certain physical demands required for the position.Regularly required to sit at a desk and use a computer
• May occasionally be required to stand, walk, bend, or reach
• Occasionally required to lift items up to 10kg, such as document boxes or computer equipment
• Work is typically performed in a standard office environment

Other Duties

This job description describes the principal duties of the position but is not intended to be an exhaustive list of all responsibilities. Employees may be required to undertake additional duties appropriate to the role and level of responsibility.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.