GMP QC Documentation Lead

Argenta (New Zealand); Scotland; On-site; GBP 32,000 - 52,000; Full time

Job summary

Argenta is hiring a QC Document Controller to own and maintain the QC document control system, ensuring SOPs, methods, specifications and records meet GMP and Data Integrity requirements. You will support the QC lab to stay inspection-ready and serve as the go-to contact for document queries.

Ideal candidates will have GMP-regulated document control experience, strong attention to detail, and the ability to work across functions, ensuring timely reviews and accurate documentation in a fast-paced

Qualifications

• Experience of document control within a GMP-regulated environment.
• Strong knowledge of GMP, Good Documentation Practice and Data Integrity (ALCOA+) requirements.
• Experience using electronic document management and quality management systems.
• Understanding of change control, CAPA, deviation and training processes.

Responsibilities

• Follow Health and Safety practices and policies and promote safe working in the QC area.
• Ensure documentation meets GMP, GDP and Data Integrity requirements; escalate when quality is compromised.
• Manage lifecycle of QC SOPs and analytical methods, including formatting, routing, approval, issue, and reviews.
• Maintain controlled specifications, test methods, validation and stability protocols with version control and traceability.
• Issue, track and reconcile logbooks, worksheets and templates; ensure records are complete and filed.
• Archive, retain and retrieve QC records per retention requirements.
• Maintain training records and track document-related training upon issue or revision.
• Support change control, CAPA and deviation actions related to documentation; track closures.
• Provide document control reporting and support audits by retrieving records.
• Administer electronic document management and quality systems and assist users with issues.
• Act as contact for QC document queries and identify process improvements.

Skills

Attention to detail

Communication skills

Organisational skills

Teamwork

Independent work

Education

HNC or Degree in Chemistry/Pharmacy/Biology

Tools

Electronic document management systems

Quality management systems

Job description

Argenta is hiring a QC Document Controller to own and maintain the QC document control system, ensuring SOPs, methods, specifications and records meet GMP and Data Integrity requirements. You will support the QC lab to stay inspection-ready and serve as the go-to contact for document queries.

Ideal candidates will have GMP-regulated document control experience, strong attention to detail, and the ability to work across functions, ensuring timely reviews and accurate documentation in a fast-paced