Job Description

Site Name: India - Maharashtra - Nashik Site
Posted Date: Mar 27 2023
Ready to help shape the future of healthcare? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, were making the most significant changes weve made to our business in over 20 years. Were on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if youre ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Job Purpose : He/She is accountable for the following activities;

• Quality Oversight of Production activities of Value Stream I (Tablets) and Value Stream II (Creams & Ointments) for ensuring compliance to GMP and Quality Management Systems requirements.
• Planning and Overseeing activities of ~10 executives involved in shopfloor quality oversight.
• Prompt escalations and resolution of GPM/ QMS issues at shopfloor.

Key Responsibilities :

• Oversight of bulk/ intermediate/ finished product manufacturing & release processes for regulatory & QMS compliance
• Contact point for any quality issues in manufacturing/ packing operations at site.
• Supporting shift-based quality oversight to ensure real-time compliance to procedures, DI and other cGMP requirements.
• Ensuring adherance to in-process checks, adequate gap analysis, impact & risk assessments as per the QMS requirement.
• Ensuring compliance with QMS and 100% adherence to training plan for self & team.
• Ensuring requisite SOPs are in-place, in-use and meet all regulatory and QMS expectations.
• Ensuring manufacturing and packing of products as per respective approved MFR/ BMR and MPR/ BPR respectively.
• Ensuring effective GMP & QMS implementation and prompt escalation of issues through relevant systems & processes.
• Handling of quality deviations and implementation/ facilitate implementation CAPAs.
• Leading/ facilitating prompt investigations of manufacturing/ analysys & product quality related deviations/ incidents.
• Participating in LICs/PIRC as per requirement and Real Time Notifications escalations at site for major/critical quality issues.
• Conducting/ supporting self-inspections & internal audits and ensuring timely compliance to audit observations.
• Reviewing of Periodic Product Review and Product PPA trend and timely escalating findings and their closure.
• Support implementation of QIPs for Quality department.
• Support various qualifications/ validations on site.
• Acively support all time inspection readiness and 100% DI compliance drives.

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

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its 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. Were 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. 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in gsk.com, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.