Lab Compliance Lead

Job Purpose

Accountable for the following activities;

• Supports to the Laboratory functions to handle Investigations, Deviation Management, Specifications ,test methods, method validations equipment qualifications ,internal audits and escalations if any.
• Support to the Laboratory functions to meet compliance as per current requirements.
• Internal audits, GLP compliance, Lab Investigations, Lab Safety, Risk management related to Quality department and Values & expectation of the Organization.

Key Responsibilities

• To lead laboratory investigation through OOS, incident investigations and deviation management.
• To provide authorization/approval of QC documents.
• All related QC SOPs, PQS for product and RMS,PMSP for material preparation and review.
• 100% CAP/ATS compliance for Instruments.
• To ensure adequate QC support to smooth implementation of new products at site.
• Improve capability of analysts.
• To escalate the stability failure, OOT trend situation through LIC.
• Management of CAP revisions gap assessments and change communication to respective SOP author.
• To ensure compliance to EHS  in QC areas of operation.
• Reduction in the cGMP noncompliance coming from   L1/L2/L3/L4 audits & WHO audits.
• Handling and maintenance of electronic systems (e.g. Empower,MERP, VQD, VQMS, SLIMS etc.)
• Control on Lab. Related SOPs Preparation and Review as per the schedule.
• To ensure continuous improvement in laboratory working and to impart training to QC staff.
• Drive improvements with respect to defect reduction in laboratory.
• Prepare plan for L1 audit for QC with related documents and  follow-up action of CAPA closure and change control.
• Verify compliance to GMP,Good Laboratory practice and Schedule L1of D & C act
• To ensure the training compliance of QC personnel with the OJT/Analyst Qualification /My Learning modules and QMS training in time.
• To ensure SOPs for area are under control are valid and meets all regulatory and QMS requirements
• Control and maintenance of documents including the quality systems as per the requirement of regulatory authorities which involves all raw data, SOPs, documentation exhibits, Protocols, training.
• To ensure instrumental audit trail program reviewed and documented periodically.
• To ensure compliance requirements and inspection readiness.
• Support the department head to establish the activities assigned or identified "as and when basis".
• Ensure compliance to GPS principles (LSW, Gemba,3Z etc)
• Reduce downtime of equipments and support for business continuity.
• Ensure calibrations and qualification activities are tracked and maintain compliance.
• To ensure safekeeping of controlled substances in the QC laboratory.

Knowledge/ Education / Experience Required

A. Educational Background

Minimum Level of Education - Minimum Level of Education

Area of Specialisation - Science/Pharmacy

Why is this Level of Education Required - To understand & co-ordinate of chemical testing  activities at Nashik site

Job-Related Experience

Minimum Level of Job-Related Experience required - 5+ years experience in Pharmaceutical Plant

Other Job-Related Skills/Background

• Attendance Management.
• People Development.
• Manpower Planning.
• Area Management.
• Site critical CIF delivery.
• Level 2 audit completion.
• Delivery of department budget.
• Quarterly OT not exceeding 105 hrs and maintaining OT budget for month.
• Ensuring no overdue QMS action in dept.

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

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.

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