Specialist - Quality

Merck; Pune District; On-site; INR 2,900,000 - 4,800,000; Full time

Job summary

Merck in Pune, India seeks a Senior Specialist - Quality / Incoming Material Release (IMR) to support material receipt and release within the Global Quality Shared Services (GQSS).

You will review documentation, ensure data integrity, and apply cGMP/GxP standards while leveraging SAP, LIMS and Veeva to drive efficient, compliant material releases across a global network.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or related field.
• 8–12 years of pharma/biopharma QA or QMS experience, preferably in materials receipt/release.

Responsibilities

• Perform receipt, review and release of incoming materials per procedures and cGMP/GxP requirements.
• Review supplier documentation to ensure compliance with specs and pharmacopoeial requirements.
• Maintain documentation and records with data integrity.
• Utilize QMS systems (SAP, Veeva, LIMS) for release activities and investigations.
• Support CAPA, deviations, changes, document management and audits.
• Collaborate with global sites and suppliers to ensure timely material release and issue resolution.
• Support quality investigations, root cause analysis and corrective actions.
• Participate in audits/inspections and training activities.
• Identify opportunities for process improvement, automation or digitization.

Skills

Quality Operations

CAPA

GxP

Documentation

LIMS

SAP

Education

Bachelors in Pharmacy or Life Sciences

Masters in related field (preferred)

Tools

Veeva

SAP

GLIMS

Job description

Specialist - Quality / Incoming Material Release (IMR)

Primary Activities

The Specialist will be part of the Quality team and will be responsible for supporting Incoming Material Receipt and Release activities while contributing to broader Quality Systems, compliance and continuous improvement initiatives within the Global Quality Shared Services (GQSS).

Key responsibilities include, but are not limited to:

• Perform receipt, review and release of incoming materials in accordance with approved procedures, specifications, cGMP/GxP requirements and applicable regulatory standards, ensuring Right First Time and turnaround time KPIs are consistently achieved.
• Review vendor, supplier and external laboratory documentation associated with material receipt and release to ensure compliance with approved internal specifications, applicable pharmacopoeial requirements and Quality standards.
• Complete and maintain all documentation and records in compliance with cGMP/GxP requirements, ensuring accuracy, completeness and data integrity.
• Demonstrate proficiency in relevant Quality and business systems, including Veeva, SAP, GLIMS and other applicable electronic Quality Management Systems.
• Interpret and apply company test specifications, quality standards, procedures and applicable pharmacopoeial requirements in day-to-day activities.
• Collaborate with global manufacturing sites, Quality teams, suppliers, external laboratories and other stakeholders to support timely material receipt and release and resolve issues impacting business continuity.
• Support Quality investigations, root cause analysis, impact assessment, CAPA development and implementation, as applicable.
• Support audit and inspection readiness activities and participate in internal and external audits/inspections, as required.
• Ensure adherence to applicable Quality Systems, procedures, policies and regulatory requirements within the department.
• Identify and contribute to opportunities for process improvement, simplification, standardization, automation and digitization within assigned areas.
• Leverage AI, automation and other digital tools, where appropriate, to simplify routine activities, improve efficiency and enhance Quality operations while maintaining compliance and data integrity.
• Provide training, coaching, guidance and knowledge sharing to junior team members and contribute to building team capability.
• Demonstrate effective teamwork and contribute positively to a collaborative, inclusive and high-performing team environment.
• Take ownership of assigned activities and deliverables, proactively identify risks, resolve issues and elevate appropriately when required.

Qualifications, Skills & Experience

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Biochemistry, Microbiology or a related scientific discipline.
• 8-12 years of relevant experience in the pharmaceutical, biopharmaceutical or healthcare industry, preferably in Quality, Quality Operations, Quality Control, Quality Assurance, material management or related functions.
• Strong practical experience in material receipt, review and release or a comparable Quality Operations environment.
• Working knowledge of Quality Management Systems (QMS) and key Quality processes such as deviations/investigations, CAPA, change control, document management, training and audit/inspection management.
• Experience working with or contributing to Product Quality Reviews (PQRs), including familiarity with the purpose, inputs, data review and quality assessment involved in the process.
• Good understanding of cGMP/GxP requirements and applicable regulatory expectations, with the ability to interpret and apply relevant standards and procedures.
• Experience working with Quality and business applications such as SAP, LIMS and electronic Quality Management Systems.
• Demonstrated ability to work effectively with global stakeholders and cross-functional teams, including manufacturing sites, Quality functions, suppliers and external partners.
• Strong communication, interpersonal and stakeholder-management skills, with the ability to communicate complex Quality topics to different audiences.
• Demonstrated ability to take ownership, make sound decisions, manage priorities and drive assigned activities to completion.
• Experience identifying and implementing process improvements, automation or digital solutions to improve efficiency and simplify day-to-day activities.
• Practical exposure to Artificial Intelligence (AI) tools and their application in day-to-day work, including the ability to identify opportunities to use AI, automation, AI agents or other digital solutions to improve productivity and simplify routine processes.
• Strong team orientation, with demonstrated ability to collaborate, share knowledge, mentor colleagues and contribute to a high-performing team culture.
• Experience working in a Global Quality Shared Services (GQSS) model or globally distributed Quality organization would be