Team Member

3 days ago

india Dr Reddy's Laboratories Limited Full time
Job Description

Job summary
We are seeking a Validation to oversee the compliance of revalidation schedules across sterile injectables (Manufacturing, Quality Control, and Development). This pivotal role involves validating/revalidating facilities, utilities, equipment, and processes in strict accordance with applicable regulatory guidelines, ensuring adherence to regulatory requirements.
Roles & Responsibilities
• You will be responsible for ensuring compliance with the periodic revalidation schedule for facility, equipment, Media fill in Production, QC (Quality Control), and development areas. Your role includes adhering to the VMP (Validation Master Plan), resource planning, and overseeing the execution of revalidation processes.
• You will be responsible for development and review of Validation master documents such as VMP, validation plan, Standard Operating Procedures, Process validation and Cleaning validation protocols and reports in accordance with current GMP (Good Manufacturing Practices), company standards, policies and other regulatory requirements.
• You will be responsible for timely implementation of new systems and improvements with respect to validation in accordance to applicable regulatory guidelines, and closure of change controls.
• You will involve in validation activities as part of the facility design, equipment and utilities by developing and reviewing URS  DQ (User Requirement Specification Design Qualification), FAT (Factory Acceptance Test), SAT (Site Acceptance Test), MC (Master Configuration), CTP (Commissioning Test Protocol), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) and VQ (Validation Qualification) in accordance with applicable regulatory guidelines.
• You will be responsible for maintaining a close liaison with engineers and vendors regarding facility and equipment items to ensure provision of accurate information, along with vendor package of qualification documentation.
• You will support FATs, SATs, IQ/OQ plant and equipment as required, advising team members to deliver best practice.
• You will be responsible for supporting internal and external audits, developing CAPA (Corrective and Preventive Actions) proposals, and ensuring QMS (Quality Management systems) compliance within the validation function.
• Additionally, your role involves goal setting, performance reviews, training, coaching, managing employee performance, and fostering a culture of recognition and appreciation to achieve individual, departmental, and business objectives.


Qualifications

Educational qualification: A Bachelor’s or Master’s in B.sc / M.sc  or Bachelor’s or  Master’s in Pharmacy
Minimum work experience: 03 to 06 years of experience in Validation and Process engineering in Pharmaceutical or sterile injectables, with at least 2 to 4 years in leading and conducting validation activities in a GMP licensed facility that includes aseptic and/or sterile manufacturing
Skills & attributes:
Technical Skills
• Strong understanding of Aseptic process, equipment, utilities, and quality systems in the pharmaceutical industry.
• Wide-ranging knowledge in the validation of equipment, processes, cleaning procedures, utilities, and facilities, emphasizing a comprehensive approach to validation practices.
• Familiarity with Computer Systems Validation, GMP and regulatory requirements for validation in the pharmaceutical and biopharmaceutical industry, including standards set by international regulatory bodies.
• Good knowledge of relevant engineering codes and standards, essential for ensuring compliance and quality in the validation processes.
Behavioural skills
• Ability to collaborate with diverse teams, including Quality Assurance (QA), QC, Engineering, Development, and Production, demonstrating effective communication and adaptability.
• Effective interpersonal skills such as communication, empathy, and harmonious collaboration with team members, contributing to a positive and supportive team culture.


Additional Information

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 digitalization 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 catalyze your career growth and professional development through personalized 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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