Job Description

Site Name: India - Maharashtra - Nashik Site Posted Date: Jan 31 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, we\'re making the most significant changes we\'ve made to our business in over 20 years. We\'re 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 you\'re 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 is accountable for the following activities Co-ordination and execution of Utiltiy, Facility, Equipment, Copmuter Systems, Process & Cleaning validations and related activities at Nashik site. Co-ordination of Computer System (GMP & GLP) related assignments at Nashik site. Co-ordination of Internal Audits (GMP / EHS) at Nashik site. Key Responsibilities Preparation, Review & Maintenance of the Site Validation Master Plan (SVMP) & Cleaning Validation Master Plan (CVMP) across the site. Execution of requalification & revalidations triggered through SVMP & CVMP. Co-ordination for preparation / review of user requirement specifications (URS) and carry out factory acceptance tests (FAT) and site acceptance tests (SAT), Design qualifications (DQ), Installation qualifications (IQ), Operation qualifications (OQ) and Performance qualifications (PQ) for new & existing equipment, utility, facility across the site. Providing support for Process Validation (PV), Cleaning Validation (CV) & Computer System Validation (CSV) and Requalification activities at the site in co-ordination with cross functional team (QC, PR&D, OQ & othe if any). Provide necessary support for access management, Data Integrity, data backup, audit trail review and date / time verification at site. Assessment of change control from validation point of view & execution of validations triggered through change control process. Deviation Management, Audit (Internal & External) Management. Review MMR / BMR / MPR / BPR of products manufactured and packed as per regulatory requirements and SOP. To identify risks (Quality / EHS / Regulatory) & report. 100 % completion of training as per training need identification in my learning. Preparation and review of Standard Operating Procedure. To complete GQP/GQMP gap analysis and to prepare / revise validation related SOPs whenever applicable. To perform transactions in dMERP (SAP) system as per respective SOP. 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, 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. 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 [HIDDEN TEXT], so that we can confirm to you if the job is genuine.

Monster