Dr. Reddy’s Laboratories: Join Our Team and Make a Difference in Global Healthcare
Vacancy Details
Selection Process: Interview (Face-to-Face)
Interview Rounds: HR Interview
Job Description
Dr. Reddy’s Laboratories is looking for an individual to join our qualification team. The ideal candidate will manage documentation and execution of qualification activities, including preparation, review, and execution of various qualification documents. Responsibilities also include overseeing new project-related tests, reviewing and compiling raw data, and ensuring compliance with validation master plans and SOPs. The role involves implementing corrective and preventive actions, conducting incident investigations, and supporting regulatory inspections.
Roles & Responsibilities
- Familiarity with cleanroom practices and behavior.
- Mandatory experience in sterile manufacturing equipment qualification.
- Preparation and execution of qualification protocols for equipment such as autoclaves, tunnels, filling and capping machines, lyophilizers, washing machines, bung processors, etc.
- Preparation and execution of qualification protocols for HVAC systems.
- Review of HVAC design documents, RDS, and all HVAC layouts.
- Review of utilities (WFI, PW, compressed air, nitrogen) design documents like DQ, P&ID, process schematics, as-built drawings, etc.
- Preparation, review, and execution of DQ, FDS, UTM.
- Preparation, review, and execution of SAT, IQ, OQ, PQ documents (protocols and reports).
- Preparation and review of risk assessment of equipment/systems.
- Review and compilation of raw data, relevant certificates, analysis test reports, and preparation and review of final summary reports.
- Compliance with GDP and ALCOA in all documentation, execution activities, and adherence to 21CFR.
- Preparation, review, and execution of SAT, IQ, OQ, PQ documents for packing and inspection equipment (protocols and reports).
Qualifications
- Educational qualification: M.Pharm.
- Minimum 5+ years of experience.
Skills & Attributes
Technical Skills
- Experience in sterile product facility validations including equipment validation, media fill, cleaning validation, process validation, area qualification, and other miscellaneous qualifications.
- Expertise in preparing, reviewing, and executing documents like URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ.
- Experience in handling incident investigations and CAPA processes.
- Experience in preparation and review of VMP and SOPs.
Behavioral Skills
- Effective communication skills for conducting training sessions and qualification activities.
- Attention to detail for documentation and reporting.
- Problem-solving skills for incident investigations and CAPA implementation.
- Efficient time management for meeting qualification schedules.
Additional Information
About the Department: Global Manufacturing Organisation (GMO)
Dr. Reddy’s Laboratories is dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. We operate 19 state-of-the-art manufacturing plants across multiple locations and are recognized by the World Economic Forum for our excellence. Our productivity improvement and digitalization efforts are key to staying competitive and achieving our ambitious ESG goals.
Benefits Offered
We offer benefits on par with the best industry standards, including joining and relocation support, family support (maternity and paternity benefits), learning and development opportunities, medical coverage for you and your family, and life coverage for yourself.
Our Work Culture
At Dr. Reddy’s Laboratories, our credo is “Good Health Can’t Wait.” We foster a culture of empathy and dynamism, supporting individual abilities while encouraging teamwork and shared success. We believe in empowering people to stay fit and healthy through innovative healthcare solutions.
For more details and to apply, please visit our career website: Dr. Reddy’s Careers
