Team Member - SIT (QC Microbiology)

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 looking for an individual for the SIT Team to oversee the investigation of major and critical deviations, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the DCMS deviations log, and providing support during regulatory inspections.

Roles & Responsibilities
• You will be responsible for overseeing the investigation of major and critical deviations from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports. Your will also be working on the trending of the deviations and identification of adequate action items for reduction of the same.
• Your role involves active participation in investigating OOS (Out of Specification) and other relevant cases, working closely with CFT members to determine root causes, CA, PA, and report writing.
• You will review minor and critical , providing constructive feedback for improvement.
• Your responsibilities include periodically assessing the trending of minor deviations, highlighting or escalating key observations, regularly reviewing the deviations log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports.
• You will offer necessary support to the site in readiness for or during regulatory inspections related to investigations.

Educational qualification: A Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline

Minimum work experience: 7 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance

Skills & attributes:

Technical Skills
• In-depth knowledge and experience in overseeing investigations, and familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA).
• Expertise in investigating valid OOS and other relevant cases.
• Familiarity with reviewing deviations / OOS log and ability to perform classification of data.
• Ability to craft comprehensive investigation reports.
• Experience in providing necessary support for regulatory inspections related to investigations.
• Knowledge of regulatory requirements pertaining to deviations investigations.

Behavioural Skills
• Ability to collaborate closely with CFT members.
• Analytical mind set for identifying root causes and developing effective solutions.
• Strong problem-solving skills and attention to detail in reviewing deviations, reports, and trending data and implementing corrective actions.
• Effective communication skills for report writing and escalation of key observations.
• Commitment to ensuring compliance with regulatory requirements in investigations.
• Ability to offer necessary support to the site in readiness for or during regulatory inspections.

looking someone with strong QC Microbiological investigation background.
Should have exp in Microbiological compliance.
Education :M.Sc. Microbiology
Exp : 8-10 Years
Industry : Injectable preferred/ OSD will be second preference
Person will be responsible to manage 3 sites Microbiological compliance at Baddi