Assistant Manager Microbiology

To perform timely analysis and ensure release of raw materials and finished products and to conduct stability studies of products and validations of sterile processes, products, equipment’s, cleaning validations, environmental and water systems monitoring in compliance with applicable QMS & Regulatory requirements.

Responsibilities

• Perform and verify microbiological analyses of oral finished products, stability samples and rawmaterials (including ampoule, eye-drop and cephalosporin testing) to ensure product quality and compliance with specifications.
• Ensure accurate documentation and logging of results and prepare and verify the reports that meet data integrity requirements for ampoule, eye-drop and cephalosporin laboratories.
• Support development, review and implementation of SOPs, conduct gap analyses against GQMPs, GQPs, USP and CAPA requirements and assist with QMS compliance in both microbiology labs.
• Provide support for GPS activities and EHS compliance across ampoule and eyedrop/cephalosporin laboratories.
• Represent and ensure Data Integrity (DI) compliance for all microbiology laboratory systems and records.
• Maintenance, qualification and calibration scheduling for microbiology equipment in both laboratories in accordance with AEQMS requirements.
• Perform and verify environmental monitoring and other data to ensure microbiological control, and document results in line with standards.
• Oversee microbiology labs and facility, method validation for microbiological test methods and support process validation activities related to microbiology at the site.
• Manage culture maintenance and relevant inventory, raise purchase orders in SAP to ensure availability of testing materials, and supervise third-party service providers as required.
• Prepare trends and summary reports for area monitoring (sterile, non-sterile and water systems), assign laboratory tasks to staff based on availability and role, and carry out routine audit trail reviews of relevant microbiological systems also act as microbiology SME during audits and regulatory interactions, drive continuous improvement, lead CI projects to closure and maintain microbiology KPIs or any other responsibility assigned from time to time as per business requirements.

Education, Experience and Skills

• BS. Microbiology / BS. Biotechnology or Equivalent is required for this role.
• Minimum 3 -5 years of relevant experience is required.
• Expert in the Microbiological operations / Testing as per regulatory requirements
• Lead the Microbiological lab / operations at site as per regulatory and QMS requirements.
• Proficient in MS-Office (Word, Excel, PowerPoint).
• Good communication and presentation skills.

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations

 

 

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Contact information:
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