Job Description

Company DescriptionDr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can\'t Wait.We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity - to strengthen our core further (the next steps) and to build the future (the new bets).\'The Next and the New\' is how we aim to continue to be the partner of choice - purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose - helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparencyDr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.Job Summary
We are seeking an individual to lead the validation and analytical method transfers for pharmaceutical materials, manage incidents and investigations, approve documents, and ensure laboratory compliance with practices and cleanliness. The role involves procurement of laboratory requirements, instrument qualifications, and calibration.Roles & Responsibilities

• You will be responsible for validation and analytical method transfers of IP (In-Process), FP (Finished Product), API (Active Pharmaceutical Ingredient), Excipients and Packing materials.
• You will initiate and investigate CRN (Change Request Notice), Incidents, OOT (Out of Trend) and OOS (Out of Specification).
• You will be responsible for approval of STPs (Standard Testing Procedures), Specifications, SOPs (Standard Operating Procedures), Protocols and Analytical test reports.
• You will ensure Good laboratory practices, Safety practices, Good documentation practices and ensure the cleanliness of the laboratory.
• Establishment of Microbiology Laboratory - Procedures and Processes to meet the Aseptic Processing Support and Sterile Drug Product Testing
• Managing the Microbiology and Sterility Assurance Projects

• Establishment of Microbiological Monitoring Program for Sterile Drug Product Manufacturing facilities through risk assessment
• Media Fill Design and Improvements - Dry Powder / Liquid Filling / Lyophilized Injections
• Trend Analysis of Microbiological Results - EMP Results and Water Testing Results
• Critical Investigations - Out of Alert / Action Levels, Media fill failures, Aseptic manufacturing related investigations and Water System failures

• Shop-floor compliance verification at sterile drug product manufacturing facility and microbiology laboratory.
• Performed risk assessments for determining gaps in Sterility Assurance and identification of corrective actions - Media Fill, Material Transfer to Clean rooms, Clean room Behavior, Supplier Quality, Cleaning and Disinfection, Sterilization Practices, Dynamic Airflow Studies and Environmental Monitoring program.
• Performed site level internal audits and vendor quality audits (planning and execution) to verify the compliance to regulatory requirements and Sanofi Global QMS expectations.
• Coordination with Sanofi global team for global vendors (Supplier and service providers) qualification etc.
• Handling the change controls/ deviations/CAPA related to material management related to aseptic manufacturing and microbiology.
• Review and approval of Microbiological Test Method Validation Protocols and Reports - Bacterial Endotoxin Test, Sterility Testing and Microbiological Examination of Non-Sterile Products etc.
• Follow-up of corrective and preventive action plans from Suppliers, distributors and service providers and to ensure the closure considering the effectiveness.
• Ensuring the response to the regulatory audit observations are provided within stipulated time
• Data trending analysis for the microbiological analysis, and evaluation to determine the potential risks and opportunities for the improvement.
• Accountable for the compliance and analytical assurance of the microbiological analysis performed within the laboratory.

QualificationsEducational qualification: An M.Sc. degree in MicrobiologyMinimum work experience: 15 to 17 years of experienceSkills & attributes:Technical Skills

• Expertise in method validation and analytical method transfers for IP, FP, API, Excipients, and Packing materials.
• Knowledge of calibration and performance verification of analytical instruments and equipment as per the master schedule.
• Experience in ensuring the maintenance, preparation, and procurement of laboratory standards, chemicals, and solvents according to established procedures.
• Participation and organization of equipment/instrument qualifications and change control mechanisms.
• Procurement expertise for laboratory requirements.

Behavioural Skills

• Attention to detail and commitment to ensuring compliance with QMS documents, including OOS, OOT, and Incident investigations.
• Ability to respond to internal and external audits and participate in other QMS-related activities.
• Strong organizational skills for LIMS related activities.
• Effective communication and collaboration skills for coordinating and implementing CAPAs.

Additional InformationAbout 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 https://careers.drreddys.com/#!/

Dr. Reddy's Laboratories