QC Team Leader (Technical Support)

Piramal Pharma Ltd; Grangemouth; On-site; GBP 52,000 - 72,000; Full time

Job summary

Piramal Pharma Solutions is seeking a QC Team Leader (Technical Support) to guide the QC Equipment Team in release testing of raw materials, intermediates and finished products. The role requires SME-level knowledge of analytical equipment and QC activities, with emphasis on cGMP, data integrity, and personnel training.

You will manage procedures, audits, and CAPA processes, ensuring clean, compliant laboratories and timely project support for client initiatives and SOP-driven workflows.

Qualifications

• SME for Analytical Equipment aligned to client projects.
• SME for QC activities aligned to client projects.
• Experience with analytical testing of raw materials, intermediates, and finished products.

Responsibilities

• Lead and coordinate the QC Equipment Team to support release testing.
• Ensure compliance with cGMP and data integrity requirements (Annex 11, 21 CFR Part 11).
• Train and develop QC Analysts and Technicians in procedures and safety.
• Manage deviations, change controls, OOS, or CAPA investigations in a timely manner.
• Ensure accurate reporting and readiness of laboratories for inspections.

Skills

QC Leadership

GMP Knowledge

Data Integrity

SOP Management

Analytical Methods

Tools

Analytical Equipment

Job description

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

QC Team Leader (Technical Support)

Job Description

Team Lead for the QC Equipment Team.

To manage and co-ordinate Quality Control department equipment required for the release testing of raw materials, in process products, bulk drug substance, final products. To be the point of contact for client projects, manage expectations and requirements and deliver against the S& OP.

• Be the Subject Matter Expert (SME) for all Analytical Equipment aligned to client projects
• 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 escalates 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 complieswith 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.