Assistant Manager Quality

To ensure equipment calibration and maintenance of instrument of laboratory operations Penicillin as per cGMP, regulatory and QMS requirements, reporting to the Lab Operations Manager Penicillin.

Responsibilities

• Ensure compliance elements while working within operations environment.
• To ensure the Quality of the Products as per GSK Standards.
• Manage all NIP requirements of Lab Operations Penicillin & Managing Purchase Order (OPEX) Management in Ariba and GRN punching, including ePIP for new purchase of Asset in CAPEX.
• To manage Management Monitoring Level 1 Audit of Lab Operation, be a team member / Lead of the self-inspection / level-1 Audit & To comply with the audit reports of Level 1, Level 2 & 3 audits for effective improvements.
• Reporting of OOS/atypical results to manager & assisting in investigations of OOS/atypical results.
• Maintaining equipment according to SOPs and manufacturer’s guidelines & ensure timely calibration / maintenance of equipment.
• To Manage the all-laboratory equipment as an Administrator & To Manage HPLC equipment empower software as a Lead User.
• Following EHS standards and guidelines attend workshops and adhere to SOPs & Reporting EHS adverse events.
• Support in laboratory equipment validation, Timely closure of VQD actions & Support to raise change controls and timely closure and implementation of change.
• Facilitate in purchasing equipment, chemicals, reagents, solvents, documentation and in testing activities.

Education, Experience and Skills

• Master’s degree in Chemistry, Pharmacy, or a related science discipline.
• Minimum 5 years of laboratory experience in the pharmaceutical, biotech or other regulated industry.
• Practical experience in routine analytical or microbiological testing.
• Knowledge of Good Manufacturing Practice (GMP) and basic regulatory requirements.
• Proficiency with MS Office applications and familiarity with laboratory information systems or electronic records.
• Strong written and verbal communication and accurate documentation skills.
• Experience with validation activities: equipment qualification (IQ/OQ/PQ), method validation or cleaning validation.
• Hands-on experience with laboratory instrumentation, calibration and maintenance practices.
• Familiarity with SAP, LIMS or other ERP, ARIBA,FIORI,EMPOWER,VEEVA,KNEAT systems for sample and inventory management ARIBA,FIORI,EMPOWER,VEEVA,KNEAT
• Previous involvement in investigations, CAPA implementation, or internal audits.
• Knowledge of environmental monitoring, water systems testing or microbiology techniques.
• Commitment to continuous improvement and a strong attention to detail.

Skills

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

 

 

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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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