- Reviewing and approving validation lifecycle documents
- Oversight of internal and external quality processes like change control and deviation investigations
- Supporting project work and providing regulatory risk reduction guidance
- Relevant experience in the biopharma/pharmaceutical industry within the Quality Assurance domain
- Knowledge of validating analytical systems, cold chain storage, manufacturing equipment, utilities, and infrastructure
- Capacity to manage workload efficiently in a dynamic environment
- Excellent organizational, interpersonal, written, and verbal communication skills
- Ability to work collaboratively and independently
- Experience with Quality activities like Deviations and Change Controls
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Quality Assurance Manager - Ware, United Kingdom - LANCESOFT LTD
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Description
Job Title: Quality Manager - Level 3
Company: Pharmaceutical Research & Development
Location: Hertfordshire
Duration: 6 months
Onsite Role
Hours per Day: 7.5
Hours per Week: 37.5
A broad QA role requiring experience in QA documentation for various equipment and processes such as blenders, chillers, powders, HPLC's, and more. This position involves validating infrastructure and utilities, reviewing change controls, audits, and deviations.
About the Company:
Our company specializes in manufacturing and supplying medicines and vaccines worldwide. Our dedicated teams oversee every step of production, from manufacturing high-quality products to ensuring effective supply forecasting and regulatory compliance, all powered by digital technologies and analytics. With a significant production scale, we delivered over 1.7 billion packs of medicine and 767 million vaccine doses in 2021.
We are continuously evolving our processes to introduce new products efficiently while emphasizing quality, safety, and service. As we embrace technological advancements and expand our product range, we are seeking top talent to join us on this transformative journey.
QA Role Overview:
If you are a Quality Assurance Professional looking to enhance your validation expertise and collaborate with internal and external partners in Pharma R&D, this role is for you.
Tasks include troubleshooting diverse scenarios, offering solutions, and ensuring quality and patient safety are upheld. You will engage with various teams, gaining exposure to project management, pilot plant systems, analytical systems, and more.
This position is based at Ware R&D.
Job Purpose:
As part of the Pharma R&D Infrastructure and Validation team, you will be responsible for quality assurance activities and oversight of Validation and GMP facilities management across UK sites.
In this role, your key responsibilities include:
Preferred Qualifications & Skills: