Team Member Qualification
2 weeks ago
Job Summary
We are looking for an individual for the qualification team to manage the documentation and execution of qualification activities, including the preparation, review, and execution of various qualification documents. The ideal candidate will oversee new project-related tests, review and compile raw data, and ensure compliance with validation master plans and SOPs. Additionally, responsibilities include implementing corrective and preventive actions, conducting incident investigations, and providing support during regulatory inspections.
Roles & Responsibilities
- Must be aware of cleanroom practices, and behavior.
- Experience in sterile manufacturing equipment qualification is mandatory.
- Preparation and Execution of qualification protocols for Equipment's, Autoclave, Tunnel, Filling and capping machine, Lyophilizer, Washing machine, bung processor etc.
- Preparation and Execution of qualification protocols for HVAC system.
- Review of HVAC designs documents, understand on RDS and all layouts of HVAC.
- Review of Utilities (WFI, PW, Compressed air, Nitrogen) designs 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's / systems.
- Review & compilation of raw data, relevant certificates, analysis test reports and preparation and review of final summary reports.
- Must follow GDP and ALCOA in all documentation, execution activities and compliance to 21CFR.
- Preparation, review and execution of SAT, IQ, OQ, PQ documents for Packing and inspection equipment's (protocols and reports).
Educational qualification: An M.Pharm.
Minimum work experience : 5+ years of experience
Skills & attributes:
Technical Skills
• Experience in working with sterile product facility related validations such as equipment validation, media fill, cleaning validation, process validation, area qualification, and other miscellaneous qualifications.
• Expertise in preparation, review, and execution of documents, including 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.
Behavioural Skills
• Effective communication skills for conducting training sessions and qualification activities.
• Attention to detail for preparing and reviewing documentation and reporting.
• Application of problem-solving skills in incident investigations and CAPA implementation.
• Efficient time management for meeting qualification schedules.
About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such 'factories of the future' is integral to innovation and to build healthcare of the future.
Benefits Offered
At Dr. Reddy's we actively help to catalyse your career growth 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
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