GlaxoSmithKline Pharmaceuticals Ltd is an Indian research-based pharmaceutical and healthcare company, and a subsidiary of GSK. The company’s product portfolio includes prescription medicines and vaccines. Its prescription medicines range across therapeutic areas such as anti-infectives, dermatology, gynaecology, diabetes, oncology, cardiovascular disease, and respiratory diseases. It also offers a range of vaccines, for the prevention of hepatitis A, hepatitis B, invasive disease caused by H,influenzae,chickenpox, diphtheria, pertussis, tetanus, rotavirus, cervical cancer, and others.
- Vacancy details:
- Department : Assistant Manager / Executive – Operational Quality
- Qualification: B. Pharm / B. Sc./ M. Pharma / M. Sc.
- Salary: ₹ Not Disclosed
Job Description: Greetings from GlaxoSmithKline Pharmaceuticals Limited...!!
- Important Details :
- Location: Maharashtra – Nashik Site
- Post of date:11/06/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
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
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
