QC Team Leader (Clinical ADC)

Piramal; Falkirk; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global healthcare company in Scotland is looking for a Quality Control Subject Matter Expert. Responsibilities include managing analytical testing for raw materials and final products while ensuring compliance with cGMP practices. The role requires effective communication, organization, and the ability to lead a team. Ideal candidates will have a strong attention to detail and a solid understanding of scientific processes. This position offers opportunities for continuous improvement and a supportive team environment.

Responsibilities

• Be the Subject Matter Expert (SME) for all QC activities aligned to client projects.
• Manage analytical procedures for testing raw materials and final products.
• Ensure QC team compliance with best cGMP working practices.
• Conduct activities in compliance with ESH requirements.
• Manage on-time reporting and documentation standards.

Skills

Highly organized

Effective communication

Ability to motivate and organise a team

Attention to detail

Understanding of scientific and technical processes

Problem solving

Ability to prioritise

Job description

KEY ROLES/RESPONSIBILITIES:

• Be the Subject Matter Expert (SME) for all QC activities aligned to client projects
• Manage analytical procedures, for testing of raw materials, in process products, bulk drug substance, final products and stability products according to defined by SOP´s, and protocols and ensure that the QC team is in compliance with the same.
• Apply best cGMP work-practices and techniques to manage the testing and release raw materials, in process products, bulk drug substance, final products and stability products within specification and in accordance with Data Integrity requirements, Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data
• Ensure that all QC Analysts, QC Technicians are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
• Ensure subcontract of QC testing and dispatching to approved suppliers is performed according to defined procedures and in compliance with GMP.
• Manage on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the Senior QC Analysts and QC Analysts
• Immediately elevate and report any deviations to materials, facilities, processes or procedures to the QC Manager
• Be accountable for the analytical laboratories being clean, tidy and well organized and in a state of continuous inspection readiness.
• Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Issue, manage and close-out deviations, change controls, OOS or SST investigations and CAPA´s in a timely fashion
• Identify areas for continuous improvement and elevate those to the QC Manager.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
• To undertake any other duties as requested by the line manager in accordance with company requirements.

KEY COMPETENCIES:

• Highly organized
• Effective communication
• Ability to motivate and organise a team
• Attention to detail
• Understanding of scientific and technical processes
• Problem solving and investigation of deviations
• Ability to prioritise, provide updates to senior management
• Dealing with external and internal clients and meeting deadlines