Company Description Dr. 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 and to build the future.
'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.
Dr 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.
Job Description 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.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.Performed site level internal audits and vendor quality audits to verify the compliance to regulatory requirements.Coordination with global team for global vendors qualification.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.Follow-up of corrective and preventive action plans from Suppliers, distributors and service providers.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 improvement.Accountable for the compliance and analytical assurance of the microbiological analysis performed within the laboratory.Qualifications Educational qualification: An M.Sc. degree in Microbiology.
Minimum work experience: 15 to 17 years of experience.
Skills & 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.Experience in ensuring the maintenance, preparation, and procurement of laboratory standards, chemicals, and solvents.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.Ability to respond to internal and external audits.Strong organizational skills for LIMS related activities.Effective communication and collaboration skills for coordinating and implementing CAPAs.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.
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.
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.
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