AddressPosted Date: Mar 21 2024
Job Purpose
The incumbent is accountable for Quality oversight and ensuring GMP compliance on the production shop floor on day to day basis from Operational Quality point of view through GMP rounds, documentation review and acts as the first contact point for any Quality issues in area of operation.
Key Responsibilities
- Ensures compliance and inspection readiness
- Ensure right first time line clearance
- Ensures that the activities on shop floor are in compliance with regulatory and QMS requirements
- Ensures timely compliance to all audit observations in the area
- Routine GEMBA and ensures timely closure of GEMBA observations
- In-process checks & Log book review
- BMR review and subsequent compliance review & PPA - Trending
- To perform transactions in dMERP (SAP) system as per respective SOP.
- Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP.
- Batch release status tracking & communication
- Ensures that the manufacturing & packing operations on shop floor are in compliance with regulatory and QMS requirements
- Ensures support provided for timely compliance to all audit observations in the area.
- Reviews Master BMR / draft MFR of products manufactured and packed in area of operation as per regulatory requirements and SOPs.
- Deviations/ Incidences in Dept. with Rapid Response, Participates in RCAs
- Support L1, L2, L3 & L4 and conduct Self Inspections as per schedule
- Reviews SOPs and ensure SOPs for area are In Place, In Use and meet all regulatory and QMS requirements
- Ensures random verification of on-line activities like in-process checks
- Carrying out the gap analysis and risk assessments as per the requirement
- Carrying out verification of area documentation like batch records, log books, status labelling etc.
- Misc. doc review- MRN/ BMR return/Online rejections/ Additional page requests/MSO etc.
- Inter OQ communication & training & coaching for capability building
- TrackWise/ VQMS/ VQD or other system actions completion & Stability sample tracking
- Ensure that all risks for department are identified, assessed and mitigated in accordance with risk management principles.
- Supports internal delivery performance & Supports various validations on site.
- Supports GPS roll out at site & Supports implementation of QIP for Quality department
- Performs assigned Quality task as per requirement.
- Demonstrates engagement to raise GEMBA Kaizen, to effectively utilize GPS tools as day to day ways of working.
- Level 1 audit completion & support closure of deviations in 15 days
- No open ZAP> 90 days pending for closure.
- Proactive identification of risk in the area
Education Required
- B. Pharm / B. Sc./ M. Pharma / M. Sc.
Other Job-Related Skills/Background
- Knowledge of Regulatory & QMS Requirements
- Good knowledge of computer software (Word, Excel and Power Point)
- Good interpersonal, Excellent oral and written communication skills.
- Ability to problem-solve and use own initiative
At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
LI-GSK
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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