Executive/Assistant Manager - Quality Management System (QMS)

Company Overview

We are dedicated to producing dependable, high-quality medicines and vaccines that meet patient needs and drive our success. Our network of 37 manufacturing sites supplied 1.7 billion medicine packs and 409 million vaccine doses in 2024, offering impactful health solutions globally. Our supply chain is fundamental to our operations and the swift, quality delivery of innovations. Technology plays a key role in enhancing manufacturing through robotics, digital solutions, and artificial intelligence.

Position Meaning and Scope

This role involves leading and supporting Quality Management System (QMS) activities at our Nashik site. Collaboration with manufacturing, engineering, regulatory, and supply teams is essential to ensure safe, compliant, and timely product supply. Candidates with integrity, clear communication, practical decision-making, and data-driven approaches will find this a role with tangible impact and career growth opportunities.

Key Responsibilities

• Oversee daily quality management system operations in production and quality control ensuring compliance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
• Implement and maintain local QMS processes such as change control, corrective and preventive actions (CAPA), and risk assessments.
• Manage QMS documentation including review, issuance, archiving, and disposition.
• Lead and support investigations related to deviations, incidents, and customer complaints.
• Conduct and assist with internal audits, self-inspections, and routine quality reviews to maintain readiness for inspections.
• Monitor and ensure achievement of key performance indicators (KPIs).
• Perform gap assessments and oversee actions for implementing GSK and regulatory systems along with pharmacopoeia compliance.

Candidate Profile

This position requires regular on-site presence with active engagement on the production floor and in cross-functional meetings. We seek curious, honest individuals focused on quality and patient safety who embrace diversity and inclusion.

Essential Qualifications and Experience

• Bachelor’s or Master’s degree in pharmacy, life sciences, chemistry, biotechnology, or closely related field.
• At least 5 years’ experience in GMP or QMS operations, or quality assurance within regulated manufacturing environments.
• Solid practical understanding of GMP and quality management systems.
• Experience handling investigations, deviations, and CAPA processes.
• Good knowledge of Drugs and Cosmetics Act including Schedule M and familiarity with international regulatory requirements.
• Proficient communication skills in English, capable of working collaboratively across teams.

Preferred Skills and Attributes

• Master’s degree specialization in relevant areas (pharmacy, life sciences, chemistry, biotechnology).
• Experience with advanced IT skills including electronic batch records, manufacturing execution systems, and SAP quality processes.
• Exposure to internal/external audits and preparation for inspections.
• Competency in root cause analysis and continuous improvement methodologies.
• Proven track record in leading or supporting quality enhancement projects.
• Extensive knowledge of both Indian and international regulatory standards related to manufacturing and distribution.

Personal Qualities

• Detail-oriented with a practical, solution-driven mindset.
• Exemplifies honesty and accountability prioritizing patient safety.
• Eagerness to learn, develop skills, and collaborate across teams.
• Able to manage activities efficiently balancing rigor and risk consideration.

Additional Information

Applications are welcomed from candidates ready to contribute to advancing quality excellence and patient safety. We are committed to an inclusive recruitment process and offer support for candidates requiring accommodations.

Note for recruitment agencies: Our company strictly prohibits accepting candidate referrals without prior written authorization. Any unauthorized referrals will not lead to fees or agreements.

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