Assistant Manager

2 weeks ago

Nashik, Maharashtra, India 703 GlaxoSmithKline Pharmaceuticals Limited Full time

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 GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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