GMP Operational Quality Senior Specialist

Talent Works; London; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A global biotechnology company is seeking a GMP Operational Quality Senior Specialist in London. This role involves providing QA support for manufacturing operations, with a focus on batch record review and compliance. The ideal candidate will have significant experience in QA within GMP environments and a relevant degree. This hybrid position offers a contract length of 12 months.

Qualifications

• Demonstrated experience providing QA support for GMP manufacturing.
• Experience in batch disposition of sterile and biologic products.
• Ability to lead investigations and CAPAs.

Responsibilities

• Review and approve batch records and deviations.
• Support GMP release of raw materials.
• Identify compliance risks in GMP processes.

Skills

QA support of GMP manufacturing operation

Batch review for sterile products

Root Cause Analysis

Critical Thinking

Problem Solving

Education

Bachelor's degree in biotech/Lifesciences

Tools

Oracle

TrackWise

Veeva

Job description

Role: GMP Operational Quality Senior Specialist

Company Name: Vertex Pharmaceuticals

Type of Role: Contract position, Inside IR35

Contract length: 12 months

Location: Hybrid, 3 days on site in Paddington, London.

Department: Operational Area Quality

Overview

Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

This role is recognized as an expert internally in the principles and application of quality assurance and compliance. The person will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs. This role will be primarily focus on batch record review, archival & support activities related to product disposition activities.

Key Duties & Responsibilities

• Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
• Support on archiving activities.
• Support QA execution of process and OOS investigations, and associated CAPAs.
• Support for approval of COAs and product labelling.
• Provide manufacturing support and guidance for GMP product quality impact assessments at the Contract Manufacturers.
• Support GMP release of incoming raw material and components.
• Participates and supports in compliance activities and help drive the closure of any observations by partnering with Vertex Compliance and Quality Assurance for CDMO and CTO activities.
• Responsible for identifying compliance risks and gaps for GMP processes.
• Record and maintain daily/monthly/quarterly batch record metrics and assists department with required Quality System data review metrics and reporting.
• Support Cell & Genetic Program and Quality projects including Quality system, and manufacturing process/SOP improvements.

Education

• Bachelor's degree in a biotech/ Lifesciences field.

Required Knowledge/Skills

• Demonstrated experience providing QA support and oversight of GMP manufacturing operation.
• Demonstrated experience in batch review/batch disposition of sterile products, biologic products and /or ATMPs.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA.
• Experience with network-based applications such as Oracle, TrackWise, Veeva.
• Understanding of regulatory environment including quality systems and compliance.
• Ability to evaluate quality matters and make decisions utilizing risk-based approach.
• Ability to facilitate cross-functional meetings/ projects, and effectively communicate with business stakeholders.
• Critical Thinking and Problem Solving skills.

Other Requirements

• Please indicate required certifications, licenses or specialized trainings.

Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.