Job title: Executive – Quality Assurance
Company: GlaxoSmithKline
Job description: Job Description : Site Name: India – Maharashtra – Nashik Site Posted Date: Jun 9 2022 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
Job Description : Site Name: India – Maharashtra – Nashik Site Posted Date: Jun 9 2022 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. Responsibilities:- 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 ensuring that the activities on shop floor are in compliance with regulatory and QMS requirements and acts as the first contact point for any Quality issues in area of operation. . Ensures timely compliance to all audit observations in the area . BMR review and subsequent compliance review, PPA – Trending and release for batch packing performing transactions in dMERP (SAP) system. . . Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP. . 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 indepednet specimen check for each batch and random verification of on-line activities like in-process checks & Log book review . 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. . 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. Job Requirement:- Diversity Preference (If any): Male Educational Qualifications : MSc/BPharm/MPharm Years of Experience : Minimum 3 years Type of Experience : Experience in Pharmaceutical QC/QA/Manufacturing. Key Skills : Fluency in written and verbal communication Advanced computer operational/usage capabilities Expertise in data management and analysis. Any Other Specifications (Languages etc.) : English, Hindi What are the risks to the business if this role is not performed – If this role is not performed then it would significantly impact shop floor quality and compliance at site. This in turn could impact on the decisions being made in operational shifts linked with product quality, patient safety and regulatory. 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 Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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 GlaxoSmithKilne (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.
Expected salary:
Location: India
Job date: Sun, 12 Jun 2022 22:23:54 GMT
Apply for the job now!