Assistant Manager

Site Name: India - Maharashtra - Worli Mumbai

Posted Date: Aug

Job Title: Assistant Manager - External Supply Quality

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.

Job Purpose

Primary responsibilities-

• Training Coordinator - To provide support in management of organizational, personnel and training documentation, including training record, training matrix, training curricula and updating the same.
• To provide quality support to all External Supply functions as a CAPA champion.
• To facilitate ES Quality weekly escalation call and to provide support in Regional Quality Weekly Escalation by providing relevant data on weekly basis.
• Preparing and consolidating ES Dashboard and slide pack for ES Quality Council, RQC and other management meetings.
• To facilitate ESQ Tier Meetings and relevant documentation.
• To act as RMPO for ES Quality to manage the risk related activities and build risk management culture in ESQ.
• Act as Quality Alert and Quality Bulletin coordinator for ES India Rx.
• To drive Periodic Product Review Process within ES India Rx.
• To coordinate for Quality & Regulatory Intelligence (QRI) activities pertaining to ES India Rx.

Key Responsibilities

The key responsibilities of this role are mainly:

1. Training Coordinator:

• As a training coordinator, provide support in management of organizational, personnel and training documentation, including training records, training matrix, training curricula as per LSOP.
• Generation of Job descriptions for every role in the entire ES function for better understanding of roles of every individual in the organization. She/he must ensure that the responsibilities placed on any one individual must not be so extensive as to present any risk to quality and compliance.
• Identification of training needs and development of training plans accordingly. Provision of training, including induction, ongoing and refresher and covering hygiene, safety and GxP training.
• Coordinating with Global Learning & Development team for Management of Training activities within ES India Rx
• Tracking and Trending of overall Training activities within ES India Rx.

2. Quality Escalation call & Tier call

• To facilitate ES Quality Tier 01 and Tier 02 meetings at a defined frequency.
• To ensure respective profile owners update their daily/weekly/monthly data.
• To maintain all the relevant documents related to Tier meetings.
• To facilitate ES Quality weekly escalation call and to provide support in India Quality Weekly Escalation by providing relevant data on a weekly basis.
• To assess and collate data related to escalation, deviations, complaints and successes for that week and update India Supply Chain Weekly Escalation.
• To provide a daily update on any overdue/ issues and escalations if any to ESQ QMS Lead and ESQ Head.

3. ESQ Dashboard & Management Slide packs

• To ensure all the KPI targets for relevant profiles are achieved and provide the relevant data/updates in this regard to ES Quality council and other forums
• To provide support to QMS Lead by preparing and consolidating ES Dashboard and slide pack for ES Quality Council, RQC and other management meetings.

4. CAPA Champion

• To track the progress of all CAPAs generated at all ES functions for timely closure.
• Escalate any exceptions in CAPA Management in Quality Council or ES
  
  Governance forums.
• Carry out an annual review of the process so that it continues to be effective and to identify improvement.

5. RMPO for ES Quality:

• To conduct periodic departmental RMCB meeting and circulate the Minutes.
• Update status of Risk Management Process into ES India Rx Quality Council.
• To build Risk Assessment/ Management culture in ES Quality i.e identification of potential risk while performing day to day activities and management of identified risk through RMS.
• Timely escalations in relevant governance forums.

6. Quality Alert and Quality Bulletin Coordinator:

• Review all Quality Alerts and Quality Bulletin raised and check for its applicability to ES India Rx
• Ensure compliance on Quality Alert Process.
• Carry out an annual review of the process to identify improvement opportunities.
• Updates and Escalations in relevant Governance forums.

7. Periodic Product Review-

• Tracking of CMOs PPR & identified review actions for completion.
• Review of PPR and executive summary report
• Updates and Escalations related to PPR process in relevant Governance forums

8. QRI coordinator for ES India Rx-

• To ensure, all the relevant QRI communications are evaluated in coordination with sites for applicability & perform business impact assessment, if applicable.
• Coordinate with respect stakeholder for ensuring implementation of the QRI requirements

9. Additional responsibilities

• Perform Gap analysis between QMS and ES Rx India SOP
• Preparation and revision of the SOP as and when required.
• Conduct MM/IBM audits as per the schedule.
• To ensure the all-time audit/inspection readiness for above mentioned job profile.
• To ensure all the KPI targets for relevant profiles are achieved and provide the relevant data/updates in this regard to ES Quality council and other forums.
• To ensure the responsibilities and tasks mentioned in the IPTc are completed.
• To identify and log the risks in VQMS for any risks foreseen relevant to the assigned profile.
• To ensure VQMS actions related to profile are raised and completed on time.
• Any additional activities assigned by the Line manager as and when required.
• To act as a backup for performing the activities under other profiles whenever the respective profile owners are on leave

Knowledge/ Education / Previous Experience Required

A. Educational Background

Minimum Level of Education - Graduate in Science / Pharmacy discipline with minimum 5 years of experience in the pharmaceutical industry

Area of Specialisation - Broad and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/ processes

Why is this Level of Education Required?

To enable the Quality Manager to assess and manage all the quality risks and issues and carry out all the responsibilities mentioned under the given job role.

B. Job-Related Experience

Minimum Level of Job- Related Experience required

Preferably 5 plus years' experience in Quality Assurance in Pharmaceuticals formulations.

Demonstrated experience in monitoring of contract Sites, analytical expertise, managing product transfers and

Why is this Level of Experience Required?

To support the ES Quality functions and to carry out all the responsibilities mentioned under the given job role.

C. Other Job-Related Skills/Background

• Good Knowledge of Documentations / Regulatory requirements & Quality Management Systems.
• Effective verbal and communication skills, collaborative team member & team leader.
• Capable to work independently.
• Demonstrate ability to multi – tasking effectively.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage,

Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

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.

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