Site Name: UK - Hertfordshire - Ware
Posted Date: Sep 30 2024
The Quality Assurance Department at the GSK Ware Pharma Supply Chain site is responsible for ensuring that all aspects of the manufacture of products is performed in a controlled manner and meets commitments to international regulatory bodies, as well as the requirements of current Good Manufacturing Practice.
The Microbiology Laboratory team works as part of the Site Value Streams to ensure that manufactured products are compliant and fit for purpose. This includes product analysis, laboratory investigations, and trend analysis of microbiological results.
Job Purpose:
The purpose of the role is to lead a team of Microbiologists who perform analysis/identification of samples and environmental monitoring (using a range of microbial/chemical techniques). The Team Leader is skilled/proficient in Microbiological techniques (set up and use). You will support the Laboratory Manager by providing expert laboratory analytical services for the site to ensure delivery of compliant products to our customers. This includes trouble-shooting and identifying remedial actions in line with procedure and working on specific initiatives aligned to Laboratory strategy. You will oversee the execution of batch/job testing and release (for testing groups), as well as providing guidance and support to the wider Microbiology team for Safety, Quality and Supply.
This role manages approximately 10 people (including contract-workers and permanent staff).
Key Responsibilities:
* Ensure data is prepared accurately according to company, customer and regulatory requirements.
* Verify the quality and accuracy of results for material to meet pre-defined acceptance criteria.
* Ensure the team structure and training is sufficient to perform critical activities.
* Responsible for assigned items of Laboratory equipment and instrumentation or 5S standards (as an expert user, resolving issues and promoting best practice).
* Take a lead role in Continuous Improvement and support the Microbial Specialist with validation activity.
* Responsible for the safety of self and staff within the Laboratory.
* Trouble shooting activities and issues.
* Working across boundaries with our key production stakeholders.
About You:
This role would suit a motivated person who has strong experience of working in a GMP (Quality) environment. Strong people skills and a proven ability to work in a team (eg; flexible approach, good communication, planning and organizational skills) as well as good report writing skills. You should have proven expertise in product flow and trouble-shooting with a strong quality mindset. You should have knowledge/experience of microbiology laboratory testing techniques, ideally within a GMP environment (and ideally knowledge of microbiological requirements for non-sterile pharmaceutical manufacture). An excellent understanding and appreciation of the testing of raw materials and final product, as well as environmental and water testing is important. You will also have a strong continuous improvement mindset and a willingness to work towards standardized and lean working practices.
Basic Qualifications:
* Relevant qualifications and/or experience (Microbiological testing and experience of managing and planning day to day activities for a team).
* Good understanding of key microbiological methodologies.
* Knowledge of current Good Manufacturing Practice (cGMP) and understanding of its impact on own role (and the implications of not following cGMP).
Preferred Qualifications:
* Ability to perform microbial identification utilizing Gram staining, biochemical techniques and full speciation using MALDI-TOF.
* Knowledgeable in the use of laboratory software (eg; Sapphire/ LIFT and M-ERP).
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