Assistant Manager - QMS

Enzene Biosciences Ltd.; Pune District; On-site; INR 1,400,000 - 2,100,000; Full time

Job summary

Enzene Biosciences Ltd. seeks a seasoned Assistant Manager – QA (QMS) to lead and monitor the Quality Management System, drive continuous improvement, and ensure data integrity across CAPA, deviations, investigations, and change controls.

The role collaborates with cross-functional teams, prepares for regulatory inspections, and contributes to digital QMS initiatives. With 9–12 years in pharmaceutical QA, you will analyze quality data, support management reviews, and implement robust processes

Qualifications

• 9–12 years of experience in Quality Assurance with exposure to QMS in pharma manufacturing.
• Experience with Change Control, Deviations, OOS, CAPA, Investigations, and Training.
• Regulatory compliance knowledge and data integrity (ALCOA+).

Responsibilities

• Review and manage Change Controls, Temporary Change Controls, Deviations, Investigations, OOS, and CAPA, ensuring timely closure of action plans.
• Perform day-to-day operations of the Quality Management System (QMS) in compliance with internal procedures and regulatory expectations.
• Ensure systems are in place for tracking, trending, and analysis of quality data, and provide input to Management Review Meetings.
• Escalate critical quality events to management in accordance with procedures.
• Review and approve investigations related to deviations, non-conformances, and OOS results for drug product/substance.
• Actively participate in root cause analysis and ensure CAPA implementation with effectiveness checks.
• Maintain understanding of regulatory requirements related to drug product manufacturing and aseptic processes.
• Support regulatory inspections and audits with QMS documentation and responses.

Skills

Change Control

CAPA

Investigations

OOS

Data Integrity

QMS

Regulatory Audits

Root Cause Analysis

ALCOA+

Documentation

Education

M.Sc./M.Pharm

Tools

eQMS

Job description

The Assistant Manager – QA (QMS) is responsible for effectiveimplementation, monitoring, and continuous improvement of Quality ManagementSystems including Change Control, Deviations, Investigations, OOS, CAPA, andTraining systems. The role ensures compliance with regulatory requirements,data integrity, and timely escalation of critical quality events to management.The position also supports digitalization initiatives and contributes tomanagement review through quality data trending and analysis.

Key Responsibilities

• Review and manageChange Controls, Temporary ChangeControls, Deviations, Investigations, OOS, and CAPA, ensuring timelyclosure of action plans.
• Perform day-to-day operations of theQuality Management System(QMS)in compliance with internal procedures and regulatoryexpectations.
• Ensure appropriate systems are in place fortracking,trending, and analysis of quality data, and provide meaningful inputtoManagement Review Meetings.
• Escalatecritical quality eventsto management inaccordance with established procedures.

Investigations & CAPA

• Review and approve investigations related todeviations,non-conformances, and out-of-specification (OOS) resultsfordrug product and/or drug substance.
• Actively participate inroot cause analysis, ensuringscientifically sound investigations and effectivecorrective andpreventive actions (CAPA)implementation.
• Monitor effectiveness checks and ensure sustainability of CAPA.

Regulatory & Compliance

• Maintain a thorough understanding ofregulatoryrequirementsrelated to drug product manufacturing, asepticprocesses, and microbiology.
• Ensure QMS activities comply with applicablecGMP,regulatory guidelines, and data integrity requirements.
• Support regulatory inspections and audits by providing QMSdocumentation and responses as required.

Documentation & Data Integrity

• Ensuredata integrityacross quality systemdocumentation and electronic systems.
• Prepare, review, and approveSOPs, policies, andproceduresrelated to QA and QMS functions.
• Ensure document lifecycle management is followed, includingperiodic review and training effectiveness.
• Provide support forQMS digitalization projects,including implementation, validation, and user adoption.
• Identify opportunities forprocess improvementandoperational excellence within QMS activities.

Organizational & Leadership Skills

• Demonstrate strongorganizational and time-managementskills, effectively handling multiple priorities in a dynamicenvironment.
• Collaborate with cross-functional teams to promote a strongqualitycultureacross the organization.
• Strong knowledge ofQMS processes(ChangeControl, Deviation, OOS, CAPA, Investigations, Training).
• Hands-on experience withregulatory audits and inspections.
• Expertise inroot cause analysis toolsand CAPAeffectiveness.
• Sound understanding ofdata integrity principles (ALCOA+).
• Excellent communication, documentation, and stakeholder managementskills.
• Experience withelectronic QMS (eQMS)and digitalquality systems preferred.

Qualification

M.Sc. / M.Pharm (Pharmaceutical Sciences or related discipline)

Experience

9–12 years of relevant experience in Quality Assurance with strongexposure to Quality Management Systems in pharmaceutical manufacturing.