Job Summary

This role is for a Quality Documentation & Compliance Specialist responsible for preparing, reviewing, and maintaining GMP documents such as SOPs, investigations, CAPAs, risk assessments, and qualification protocols. The position involves coordinating with QA and cross-functional teams, supporting audits, and ensuring timely closure of quality notifications, CAPAs, and change controls in SAP. You will contribute to regulatory readiness by maintaining accurate documentation, coordinating audit responses, and ensuring compliance with cGMP standards.

The role emphasizes training coordination, safety and ESG participation, and fostering a culture of compliance and continuous improvement.

Roles & Responsibilities

. You will be responsible for preparing, reviewing, and updating GMP documents (SOPs, investigations, CAPAs, risk assessments, URS, qualifications).

. You will be responsible for coordinating with QA for receipt of documents and with CFTs for review and approval of master documents.

. You will be responsible for conducting regular audits to ensure documentation is current and compliant with cGMP standards.

. You will be responsible for coordinating audit responses and ensuring timely closure of quality notifications, CAPAs, and change controls in SAP.

. You will be responsible for performing incident and OOS/OOT investigations, identifying root causes, and preparing CAPAs with effectiveness checks.

. You will be responsible for coordinating training within the department, ensuring on-time completion of SOP trainings.

. You will be responsible for maintaining safety standards, participating in ESG initiatives, and adhering to compliance policies.

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You will be responsible for ensuring all quality-related documents are properly controlled, updated, and accessible for regulatory inspections.

Qualifications

Educational qualification: Graduation in Pharmacy, Post Graduation in Pharmacy, Science Biotechnology or related field is preferred

Certifications in Pharmaceutical In-Process Quality Assurance (IPQA), CDSCO Compliance, Pharmaceutical Quality Auditor or equivalent is preferred.

Minimum work experience:

10+ years of experience

Skills & attributes &Critical; exposures

Functional Skills

. Audit Planning

. Change Control

. Incident Reporting

. Pharmaceutical Manufacturing

. Quality Management

. Regulatory Compliance

. Risk Management

. Technical Documentation

Resident Skills

. Current Good Manufacturing Practices (cGMPS)

. Continuous Improvement Process

. Digital Literacy

. Good Documentation Practices

. Lean Methodologies

Behavioural Skills

. Detail-oriented with strong compliance and regulatory alignment mindset

. Collaborative across QA, production, and cross-functional teams

. Continuous improvement orientation with problem-solving and innovation

Critical exposures

. Experience in managing automated QMS Softwares for manufacturing is desired.

. Experience in conducting internal inspections, managing non-conformance including CAPA (Corrective and Preventive Actions), and handling and archiving quality documents is desired.

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Exposure to market complaint handling, deviation management, and impact assessment for compliance is preferred.

. Exposure to quality improvement initiatives and ensuring alignment with manufacturing quality standards and best practices is preferred.

Additional Information

Benefits Offered

At Dr. Reddy's we actively help to catalyse your growth opportunities and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit.

And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success.

We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website at https://careers.drreddys.com/#!/

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