Lead - Site Investigation Team for Biologics Drug Substance Manufacturing

Lead - Site Investigation Team

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 (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 Description

Job Summary
We are looking for someone who can Lead performing investigations related to Biologics Drug Substance Manufacturing, ensuring thorough root cause analysis and implementation of CAPA, crucial for maintaining product quality and compliance. The role involves reviewing incident reports related to Drug Substance Manufacturing for Biologics, collaborating with cross-functional teams, and providing mentorship to cross function to enhance investigation and reporting capabilities, ultimately fostering a culture of continuous improvement and regulatory compliance within the organization.

Roles & Responsibilities
• You will be responsible for leading investigations related to Biologics Drug Substance Manufacturing, valid OOS (Out of specification) cases, and other relevant incidents, collaborating closely with SIT (Site Investigation Team) members, site CFT (Cross-functional Teams), and operating staff to determine root cause, corrective actions (CA), and preventive actions (PA), ensuring unbiased and objective closure with high confidentiality.
• You will review Drug substance related incidents, provide improvement feedback, and periodically assess  incident trends, highlighting key observations.
• You will review incident-related reports and logs, ensuring proper classification and notifying management of findings.
• You will be responsible for using defined template for investigation report writing and provide support to sites during regulatory inspections.
• You will participate in internal/external audits and contribute actively to site review meetings from drug substance unit.
• You will facilitate the development of site CFT members' investigation and report writing skills, setting up a review and governance mechanism for SIT at the site.
• You will be responsible for presenting periodic updates on key findings, open issues, fostering strong connections between SIT, Cross functional team members, MSAT (Manufacturing Science and Technology) members, and key stakeholders of Drug Substance unit

Qualifications

Qualifications

Educational qualification: B.Pharm. or M.Pharm, B.Sc. or M.Sc. 
Minimum work experience: 8 to 10 years

Skills & attributes:
Technical Skills
• Experience in handling OOS and investigations related to biologics drug substance manufacturing, root cause analysis, CA and PA.
• Proficiency in leading investigations and applying RCA methodologies to identify underlying causes accurately.
• Experience in utilizing incident management systems, classify, and manage incidents effectively, ensuring proper documentation and notification of findings to management.
• Understanding of regulatory requirements related to incident investigation and reporting, including familiarity with KPI for investigation, report writing and support during regulatory inspections.
• Experience in participating in internal and external audits, providing support in investigation-related matters, and ensuring compliance with audit requirements and standards.
• Capacity to facilitate skill development in root cause analysis and report writing, and establish governance mechanisms to ensure the quality and consistency of investigations across the site.

Behavioural skills
• Good writing skills for preparing investigation report and technical reports.
• Strong collaborative skills to work closely with SIT members, site CFT and management, fostering teamwork.
• Excellent communication skills to convey complex technical information clearly and concisely.
• Demonstrated  abilities to lead investigations, collaboratively work with team members, and facilitate skill development, inspiring confidence and trust in the investigation process and outcomes.
• Critical thinking and analytical skills to analyse deviation-related data, identify patterns and trends, and draw meaningful insights

Additional Information

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon...

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...

 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/#!/

Experience Level

Senior Level