Assistant Manager Microbiology

GSK; Karachi Division; On-site; PKR 700,000 - 1,100,000; Full time

Job summary

GSK Pakistan is seeking a microbiology professional to perform and verify microbiological analyses of oral finished products, stability samples and raw materials, ensuring data integrity and compliance with regulatory requirements.

You will lead the microbiology lab at site, support SOPs, CAPA and QMS activities, manage environmental monitoring, equipment calibration scheduling, SAP inventory and audits, and contribute to continuous improvement with 3–5 years of relevant experience.

Qualifications

• BS Microbiology or Biotechnology required.
• 3–5 years of relevant experience.
• Expert in microbiological operations/testing per regulatory requirements.
• Lead microbiology lab/operations at site as per regulatory and QMS requirements.
• Proficient in MS-Office.

Responsibilities

• Perform and verify microbiological analyses of products and samples.
• Ensure data integrity and prepare reports meeting data integrity standards.
• Support SOP development and QMS compliance in microbiology labs.
• Oversee microbiology labs, facility, and method validation.
• Manage inventory and SAP-related tasks; monitor KPIs and audits.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Education

BS Microbiology / BS Biotechnology

Tools

MS Office

Job description

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.