Site Quality Head Sterile

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 (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 transparency

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. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary
We are seeking a qualified candidate to lead the Quality Assurance , QC Chemistry and Microbiology Laboratories for the site, The role involves developing SOPs, ensuring compliance with cGMP and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include proper review and approval of documents, execution of in-process controls, participation in investigations, vendor qualification, stability management, and ensuring safety practices.

Roles & Responsibilities
• You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology laboratories.
• You will ensure adherence to systems and procedures by all QA and laboratory personnel.
• You will be responsible for organizing contract laboratory audits and certification.
• You will formulate systems and procedures for the effective implementation of cGMP (Current Good Manufacturing Practices), GLP (Good Laboratory Practices), and other good industry practices, as well as various regulations for the manufacture, storage, and distribution of drug products.
• You will be responsible for planning and monitoring the daily activities of different sections of the department and ensure the availability of the required facility and material for carrying out the daily functions.
• You will ensure timely review and approval of all Master documents such as Standard Operating Procedures (SOP), Standard Cleaning Procedures, Guidelines, Operating Instructions, Master Production Records, Packaging configurations, Artworks and other printed packing material, specifications, Standard procedures, Record of Analysis Report, General test procedures, Cleaning Validation Protocols, Stability Protocol, Validation Protocol, Reports, Qualification Protocol, Master Validation Plan, Master Cleaning Validation, and other such reports/documents.
• You will be responsible for ensuring proper sampling of all in-process and finished products, management of reserve and stability samples, and collection of finished products.
• You will ensure proper and timely execution of the in-process controls and checks during manufacturing and packing.
• Your role includes ensuring proper review and release/rejection of finished drug product batches, evaluating and ensuring drug product recall, monitoring quantity and final disposition of recalled/returned material.
• You will participate in investigations as a site investigation team (SIT) member, and ensure proper investigations into Market Complaints to provide suitable CAPA (Corrective and Preventive Actions) to prevent recurrence.
• You will be responsible for the timely review, approval, and implementation of CAPA for all incidents, change controls, OOS (Out of Specifications) and OOT (Out of Trends).
• You will be responsible for timely and accurate vendor qualification, proper material management, carry vendor and internal audits as required, stability management, and issuance of field alerts.
• As a qualified trainer, you will be responsible for implementing training programs, ensuring compliance and imparting cGMP and SOP trainings.
• You will ensure compliance with the CAPA noted for deficiencies and observations from self-inspections, internal audits, and external audits.
• Your responsibilities include preparation and approval of Annual Product Quality Reviews, appraisal of routine activities and issues to higher management, involvement in the Adverse Drug Reaction (ADR) Reporting, and ensuring departmental adherence to safety practices.
• You will also be responsible for safety, strength, purity, and efficacy of the product, and any other assignments given by higher management.

Educational qualification: An M. Pharm/  M.Sc. with experience in Sterile products

Minimum work experience: 15 to 20 years

Skills & attributes:

Technical Skills
• Experience in recruitment and training, specifically of QA and laboratory personnel in Chemistry and Microbiology laboratories.
• Experience in establishing systems and procedures for cGMP, GLP, and other industry practices.
• Experience in handling investigations, self-inspections, internal audits, and external audits, and the ability to approve and implement CAPAs resulting from the investigations.
• Skills in vendor qualification, vendor audits, and material management.

Behavioural Skills
• Leadership and organizational skills for effective management of laboratory personnel and operations.
• Detail-oriented mind set for thorough review and approval processes.
• Strong communication and collaboration skills for internal and external audits, investigations, and compliance activities.
• Commitment to safety practices and adverse drug reaction reporting.

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