GSK hiring for Assistant Manager / Executive – Operational Quality @ Nashik, India

Assistant Manager / Executive – Operational Quality

Job description:
Site Name: India – Maharashtra – Nashik Site

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

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