University of Strathclyde

What you'll study

This programme combines taught modules on quality systems, regulation and manufacturing practice with practical laboratory and project work to develop the competencies required for GMP-compliant production. Core topics typically include:

• Principles of Good Manufacturing Practice (GMP) – statutory requirements, GMP principles for active pharmaceutical ingredients and finished products, and facility and personnel controls.
• Quality Management Systems – ISO concepts, quality assurance versus quality control, change control, deviation management and CAPA (corrective and preventive actions).
• Regulatory Affairs and Compliance – regulatory landscape, product licences, inspections, submission dossiers and post-marketing obligations.
• Validation and Qualification – validation of processes, equipment, utilities and computerized systems, plus commissioning and qualification protocols.
• Quality by Design (QbD) and Risk Management – design space, critical quality attributes, process analytical technology (PAT) and formal risk assessment approaches such as FMEA.
• Analytical Methods and Quality Control – principles of pharmaceutical analysis, assay validation, stability testing and laboratory best practice.
• Data Integrity and Computerised Systems – ALCOA principles, electronic records, audit trails and regulatory expectations for computerized laboratory and manufacturing systems.
• Sterile and Aseptic Manufacturing (where offered) – contamination control, environmental monitoring and aseptic processing considerations.
• Research Project or Industrial Placement – an extended dissertation, laboratory-based project or industry-linked placement enabling application of GMP and quality principles to a substantive problem.

Teaching methods include lectures, case studies of inspection findings, practical laboratory sessions, workshops on documentation and mock audits, and guest sessions from industry and regulators. Assessment commonly uses written examinations, coursework, reports, presentations and the project dissertation.

Entry requirements

Applicants are normally expected to hold a UK honours degree (or recognised international equivalent) in pharmacy, chemistry, biochemistry, molecular biology, biomedical sciences, chemical engineering or a closely related science/engineering discipline. A lower second-class honours degree (2:2) may be considered where the applicant has relevant professional experience in pharmaceutical or allied industries.

Applicants with substantial industry experience but without a primary degree are considered on an individual basis and may be required to provide evidence of technical competence and professional references. A demonstrable interest in quality systems, regulatory affairs or manufacturing is advantageous.

For applicants whose first language is not English, an appropriate English language qualification is required; typical expectations are a secure overall score with minimum component levels as specified by the university’s English language policy.

Career prospects

Graduates from this programme typically enter or progress within roles that ensure product quality and regulatory compliance across the pharmaceutical and related sectors. Common career paths include:

• Quality Assurance (QA) and Quality Control (QC) officers or managers
• GMP compliance specialists and auditors
• Validation engineers and validation managers
• Regulatory affairs associates and dossier specialists
• Manufacturing supervisors and production managers in sterile and non-sterile environments
• Roles with contract development and manufacturing organisations (CDMOs), biotech companies and medical device manufacturers
• Consultancy and inspectorate roles supporting regulatory submissions, inspections and remediation activities

The practical focus and project work also prepare graduates for technical roles in analytical and process development laboratories or for further research and professional development in quality systems and regulatory science.

Why study at University of Strathclyde

The University of Strathclyde has a strong applied science tradition and close engagement with industry across the life sciences and pharmaceutical sectors. The programme draws on expertise from Strathclyde’s pharmacy and chemical sciences communities and benefits from established links with local and international pharmaceutical manufacturers and regulatory bodies.

Students gain practical experience in laboratory and workshop settings and access to industry-relevant teaching, including case studies based on real inspection findings, guest lectures from practising quality and regulatory professionals, and opportunities for industry-based projects or placements. The university’s focus on employability, professional development and collaborative research makes it well suited to those seeking to move into, or progress within, GMP and pharmaceutical quality roles.