Job Description

Site Name: India - Maharashtra - Nashik Site
Posted Date: Sep 12 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:

• Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
• Ensure all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions as per the principles of GPS), Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
• Ensure accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.
• Ensure for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via PCS review, e.g. assessment of the impact of AL2/AL3 primary changes impacting API material properties (primary product owner), assessment of impact of API/excipients changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes etc
• Ensure to provide technical input to Periodic Product Reviews, and internal and external audits.
• Ensure to provide technical input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations
• Ensure a robust and well understood process and product control strategy are transferred during technical transfer and commercialization at site, and subsequent transfers to other sites.
• Responsible for the technical aspects of new product introduction to hand over to production.
• Responsible for approving and resourcing technical aspects of planned changes for launched products through effective risk management processes
• Lead the technical discussion with internal & external stakeholders at various forums like change control, project steering meetings, WAP, PTC council

Educational Qualifications - M.Pharm/Ph.D Years of Experience - 8-10 (M.Pharm), 5-6 (Ph.D) Type of Experience:

• Knowledge of regulatory environment, particularly in markets where product is commercialized.
• In depth knowledge and understanding of product dose forms and their manufacturing processes.
• Demonstrated experience in the Pharmaceutical or FMCG industry in leading the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, QbD, validation and change control

Key Skills:-

• Detailed knowledge of relevant dosage form including: unit operation understanding, functionality and criticality of formulation materials and their transformations (e.g. powder technology, colloid science, crystallization, isolation, drying and particle size reduction), plant equipment and analytical testing. Awareness of device/packaging processes.
• Understanding of Risk Assessments and FMEAs as per ICH guidelines.
• Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise).
• Knowledge of regulatory environment, particularly in markets where product is commercialized..
• Track record of improving products, processes and trouble-shooting, execution of technical activities including trials and validation activities

Any Other Specifications (Languages etc.)

• Able to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA

What are the risks to the business if this role is not performed? This role includes handling of product owner activities for products at Nashik which is extremely critical to day to day operations at the site. There are critical activities planned for Derm operations like Alu-Lami, material source changes for security of supply/PPV, Eltroxin stability improvement programs. Existing product owners are finding it difficult to manage the workload & working in reactive mode. Product owners are not able to focus on proactive problem solving, improving product performance as well as TRA updation. Hence this recruitment is crucial. 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.

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  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 askus@gsk.com, so that we can confirm to you if the job is genuine.