Overview
The Process Monitoring Team Manager provides leadership in environmental monitoring, aseptic compliance, and batch release activities, ensuring sterile manufacturing operations.
Responsibilities
* Manage and oversee routine environmental monitoring (viable and non-viable) in sterile manufacturing areas, ensuring regulatory and internal standards compliance and driving operational efficiency.
* Ensure the timely execution of time-critical testing to support production schedules and minimise operational disruptions, aligning resources effectively.
* Provide leadership and oversight during sterile operations, ensuring compliance with aseptic techniques, cleanroom behaviours, and sterility assurance practices, and resolving complex issues.
* Identify, assess, and escalate deviations or incorrect practices in sterile operations, lead investigations and ensure corrective and preventive actions are implemented to maintain compliance and product quality.
* Lead the development and delivery of training programmes to educate operators and production staff on aseptic principles and behaviours, fostering a culture of compliance and sterility assurance.
* Ensure the accuracy, completeness, and compliance of documentation for environmental monitoring and testing activities, adhering to regulatory and internal standards.
* Review and analyse monitoring data to identify trends, anomalies, or risks, providing strategic recommendations to senior stakeholders and driving process improvements.
* Collaborate with production, quality, and engineering teams to ensure seamless execution of monitoring activities during critical manufacturing operations and provide sterility assurance input to batch release.
* Oversee the batch release process by reviewing environmental monitoring data and sterility assurance assessments to ensure compliance with regulatory standards.
* Manage and support project and routine requalification studies such as smoke pattern evaluations and biological indicator testing, ensuring sterility assurance requirements are met and validated.
Qualifications
* Science related degree
* Strong experience in production and laboratory environments.
* Strong knowledge of regulatory requirements (e.g., FDA, MHRA, EMA) and industry standards (e.g., cGMP, ISO).
* Excellent problem-solving skills and attention to detail.
* Strong leadership and project management abilities.
* Effective communication and interpersonal skills.
About the employer and benefits
GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases. The site contributes revenues of ~$2Bn annually, and is a key supplier of some of GSK's blockbuster products.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. Our culture emphasizes being ambitious for patients, accountable for impact, and doing the right thing. We are an Equal Opportunity Employer.
We support an agile working culture for all roles. If flexibility is important, explore opportunities with our hiring team. For US interview expenses reporting, certain disclosures may apply under CMS Open Payments regulations.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus, healthcare and wellbeing programmes, pension plan membership, and shares and savings programmes. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model.
Discover more about Life at GSK on our webpage Life at GSK.
#J-18808-Ljbffr