Team Leader Manufacturing QMS

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.
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.
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. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :

No

Employment Type :

Full-time