Job Description

Site Name:

India - Maharashtra - Worli Mumbai

Posted Date:

Jul 21 2025

Job Purpose

LOC Complaint Handler. Handling of Counterfeit/Suspected Counterfeit incidents. Toll free service coordinator Deviation Coordinator CAPA Coordinator

Key Responsibilities

LOC COMPLAINT HANDLER

Route the customer communication Handle communication received from Tech Mahindra as per SOP for Handling calls received on Toll free number for Pharma and Vaccines Log the complaint in a validated system (as applicable) and assess criticality. Follow-up with customer and request sample unless justified that the sample is not required. Route complaint and any sample to the investigating site based on the defect observed. Assess/review if complaint is associated with HSI/AE and if it is, inform the local Pharmacovigilance (PV) representative within 24hrs. Maintain any Safety data cross-references and forward any follow-up information to the local/Global PV representative. Ensures that any HSI data cross-reference is maintained Reviews the complaint data for any other similar complaints from the role of product complaint handler. Forward complaints which are not related to product quality to concerned stakeholders (e.g.: Complaints on market shortages to distribution department, AE & SAE related to PV/Medical) Perform local trending of complaints and escalate adverse trends to Safety and/or Quality functions. Perform monthly reconciliation of HSI with the PV/safety (Global Service Provider). Escalate actions which may be overdue or at risk of non-compliance to LOC quality council. Carry out an annual review of the process so that it continues to be effective and to identify improvement. To share complaint tracker and reconciliation with global service provider.

COUNTERFEIT HANDLER:

To log the complaint for received suspected counterfeit product and record the information received. To forward the suspected counterfeit sample and received information/ documents to the manufacturing site for investigation Coordinate with LOC regulatory if any discussion with local regulators is required. Call for LIC/PIRC if the site confirms of confirmed counterfeit Coordinate with Legal Brand Protection (LBP) to report the suspected counterfeit. To escalate to Quality council as appropriate To generate AFPR report in case of confirmed counterfeit.

TOLL FREE SERVICE COORDINATOR:

To ensure SOP in place and in use. To ensure Toll free third party employee are trained on applicable trainings. Ensure Monthly KPI reporting by third party as per SOP. To provide the updates to quality council. To support third party if they have a confusion or doubt in the communication received. To provide standard response in case of repeat product queries, as applicable. To perform monthly reconciliation of Toll-free communications received as per SOP.

DEVIATION CO-ORDINATOR:

Ensure deviation are raised for nonconformance from the applicable procedures. Track and monitor all the deviations of LOC function for timely closure. Escalate critical incident / deviations at Quality Council or LOC governance forums. Monitor periodic trend reviews of deviations, including assessment of effectiveness of action taken. Escalate actions which may be overdue or at risk of non-compliance to LOC Quality Council. Report deviation KPIs to relevant governance forums and for monthly reporting as required

CAPA CO-ORDINATOR:

Implement global process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA's. Implement a local process to track and review CAPA plans on routine basis. Manage CAPA's for the entire LOC and ensure that CAPA's arising out of a non- compliance is logged into VQMS. Demonstrate that LOC effectively identifies where CAPA plans are required and that they are effectively implemented, monitored and closed out. Escalate actions which may be overdue or at risk of non-compliance to LOC Quality Council. Ensure KPIs are introduced that provide assurance that the process is effective and drives improvement. Report CAPA KPIs to relevant governance forums and for monthly reporting as required.

OTHER:

To perform the QMS gap assessment for the relevant system, where required. Preparation, revision of LSOPs as per requirement. To perform MM, Third party audits, Scoping visit of third party after appropriate qualification Identify and log risk and outline, monitor and implement appropriate mitigation plans. To collate and submit data for KPI management and other governance forum like QC, EMQC, RMCB etc. Complete mandatory trainings by the due date. Perform a job only after completion of training on that topic. Ensure that all internal procedures and systems which are in LOCQ are followed and complied with. Any additional responsibility assigned by the line manager as and when required.

Knowledge/ Education / Experience Required

Educational Background

Minimum Level of Education

-

Graduate in Science / Pharmacy

Area of Specialisation

-

Broad and through technical and regulatory knowledge of current pharmaceutical processes, QMS activities such as Complaint Management, Change control, deviations and CAPA management.

Why is this Level of Education Required?

-

To support LOC Quality and to carry out all the responsibilities mentioned under the given job role

Job-Related Experience

Minimum Level of Job-Related Experience required

Preferably 3 -10 years experience in Quality Assurance in Pharmaceutical industry. Having adequate knowledge of complaint management system and experience in handling of complaints as per quality assurance function.

Why is this Level of Experience Required

-

To support LOC Quality and to carry out all the responsibilities mentioned under the given job role

Other Job-Related Skills/Background

Good knowledge of documentation / regulatory requirements and quality management system. Breath knowledge in quality systems principles and practical application. Good knowledge of quality management tools. Demonstrated sound decision-making process, based on the facts and data, and application of Risk management principles. Exposure and competencies with respect to multiple dosage forms. Excellent verbal and communication skills, collabrative team member and team leader. Demonstrated ability to effectively multi-task. Ability to excel in execution

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 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).


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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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