Section Head - Quality Control

Dr. Reddy’s Laboratories Ltd.

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.

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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

Roles & Responsibilities

• Planning, monitoring and completion of Daily Calibrations, scheduled & Un-scheduled calibrations of analytical instruments.

• Procurement, maintenance and availability of Working Standards/ Reference standards and impurities.

• You will initiate and investigate CRN (Change Request Notice), Incidents, OOT (Out of Trend) and OOS (Out of Specification).

• To ensure the training and qualification of analysts for analytical techniques as per job descriptions in lab support section.

• Review of instruments list, calibrations / standards schedules & monitoring of calibration management through SAP/LIMS.

• To ensure the compliance for all QC instruments / equipment and creating awareness to the team on ownership and maintenance.

• 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.
• Your role involves ensuring the maintenance, preparation, procurement of laboratory standards and chemicals/solvents as per the laid down procedures.• You will participate and organize equipment/instrument Qualifications & change control mechanism, and procurement of laboratory requirements.• You will ensure calibration/performance verification of analytical instruments and equipment as per master schedule.• you will be responsible for preparation of response for Internal and external audits and other QMS (Quality Management System) related activities.• Your responsibilities will include ensuring compliance in LIMS (Laboratory Information Management System) related activities, and ensuring that all the QMS documents are investigated timely, reviewed and appropriate CAPA’s (Corrective and Preventive Actions) are taken and implemented.

Qualifications

Educational qualification:

An M.Sc. degree in Chemistry, Analytical Chemistry, or a related field

Minimum work experience:

10 to 15 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 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.

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Additional Information

About the Department

Global Manufacturing Organisation (GMO)

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. The 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 catalyze 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...

For more details, please visit our career website at https://careers.drreddys.com/#!/

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