QC Document Controller: GMP Compliant Records Lead

Argenta; Scotland; Sur place; GBP 30 000 - 42 000; Plein temps

Résumé du poste

Argenta is hiring a QC Document Controller to own the QC document control system, ensure SOPs, analytical methods and specifications are current and compliant with GMP and Data Integrity. The role supports a compliant QC laboratory and acts as a primary contact for document queries.

Responsibilities include lifecycle management of QC documents, archiving, training record maintenance and collaboration across functions to drive continuous improvement in documentation practices.

Qualifications

• Experience of document control within a GMP-regulated environment.
• Strong knowledge of GMP, Good Documentation Practice and Data Integrity (ALCOA+) requirements.
• Experience of using electronic document management and quality management systems.
• Understanding of change control, CAPA, deviation and training processes.
• Excellent attention to detail and accuracy.
• Strong organisational skills, with the ability to prioritise and meet deadlines in a changing environment.
• Good written and verbal communication skills, with the ability to work with colleagues at all levels.
• Ability to work independently, as well as part of a team across different functions, and to lead and guide team members.

Responsabilités

• Follow Health and Safety practices and policies by reporting incidents and hazards and promote safe working in the QC area.
• Ensure QC documentation meets GMP, Good Documentation Practice and Data Integrity requirements, and elevate situations where quality is compromised.
• Manage the lifecycle of QC SOPs and analytical methods, including formatting, review routing, approval, issue, periodic review and withdrawal.
• Maintain controlled specifications, test methods, and validation and stability protocols and reports, ensuring version control and traceability.
• Issue, track and reconcile controlled logbooks, worksheets and templates, and check that completed records are complete and filed.
• Manage the archiving, retention and retrieval of QC records in line with retention requirements.
• Maintain training records and assign document-related training when documents are issued or revised, tracking completion with managers and team leads.
• Support change control, CAPA and deviation actions relating to documentation, and track closure of document-related actions.
• Provide document control reporting (e.g. documents in workflow, overdue reviews) and support regulatory and client audits by retrieving and presenting records.
• Administer and use electronic document management and quality systems, support users and elevate system issues.
• Act as the point of contact for QC document queries, coach colleagues on document control requirements, and identify improvements that make document processes simpler and more efficient.

Connaissances

GMP knowledge

Data Integrity (ALCOA+)

Documentation control

Attention to detail

Organisational skills

Written & verbal communication

Independent & team work

Prioritisation & deadlines

Formation

HNC or Degree in science

Outils

Electronic document management systems

Description du poste

Argenta is hiring a QC Document Controller to own the QC document control system, ensure SOPs, analytical methods and specifications are current and compliant with GMP and Data Integrity. The role supports a compliant QC laboratory and acts as a primary contact for document queries.

Responsibilities include lifecycle management of QC documents, archiving, training record maintenance and collaboration across functions to drive continuous improvement in documentation practices.