Assistant Manager OQ – Batch Release & Engineering Oversight

Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

The incumbent is accountable & responsible for Review of Batch documents & Batch release in accordance with GSK QMS & applicable regulatory requirements and acts as the first contact point for any Quality issues in area of operation.

To improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement.

To maintain presence and be accountable for key quality decision-making or quality escalations.

To provide first line support to Engineering & Utilities areas and maintain inspection-readiness through independent checks.

Key Responsibilities (Key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role)

• Ensures compliance and inspection readiness.
• Ensures release of bulk and finished products, meeting the statutory and QMS requirements, to market.
• BMR & BPR review and subsequent compliance review, Analytical report review and CPP trending
• Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP.
• 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.
• Supports internal QMS activity for Engineering, Warehouse, Administration, PR&D,EHS,HR,Validation,L&D and Planning.
• Supports implementation of Quality Improvement Plan for Quality department.
• Support closure of deviations and investigations.
• Supports/conduct Self Inspection audit as per schedule.
• Support for internal and regulatory inspections
• Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations. Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects at Engineering & Utility areas
• Ensure adherence to frequency of oversight mandated in the Quality oversight schedule at Engineering & Utility areas and production areas.
• Foster a Quality Starts With Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety at Engineering & Utility areas.

Why You?
Work model: This role is on-site in India. Regular presence on the production floor and active participation in cross-functional meetings are required. We welcome applicants who bring curiosity, integrity, and a practical focus on quality and patient safety. We are committed to inclusion and encourage people from different backgrounds and experiences to apply.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Minimum Level of Education - B. Pharm / B. Sc./ M. Pharma / M. Sc.
• Area of Specialization - Pharmacy / Chemistry
• Why is this Level of Education Required? - To ensure the Batch Release procedure with QMS & Regulatory requirement. To ensure Operational Quality oversight across production, and related service areas. (Preferred Level of Education - Masters)
• Area of Specialization - Science/Pharmacy
• Minimum Level of Job-Related Experience required - 7 to 10 years
• Why is this Level of Education & Experience Required? - Capability to understand Regulatory, QMS & Site Batch release SOP requirement indetail.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• 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.

What we offer
A role where your work helps deliver safe, high-quality products to patients. Clear career progression and regular opportunities to learn through coaching and cross-functional collaboration. If you are motivated to grow your operational quality career and make a measurable impact, we want to hear from you.

How to apply
Please share your CV and a short note describing a recent quality issue you helped resolve and what you learned. We look forward to hearing how you could contribute and grow with us.

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing

Why GSK?

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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.