Team Member - Quality Assurance (QMS & Engineering)

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.

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Job Summary
We are looking for an individual for the Quality Assurance team to Preparation and review of APQR, Change control, and CAPA management. Facility and Equipment Qualification management, Facility and Equipment Qualification management, Preparation and review of Quality trends.

Roles & Responsibilities

• Preparation and review of Standard Operating Procedure/ Standard Cleaning Procedure / Standard Operating Instructions related to department as well as all functional departments
• Facility and Equipment Qualification management, Self-Inspection management, Investigation report review, Preparation and review of APQR, Change control and CAPA management
• Preparation, review, and approval of quality risk assessment.
• Preparation and review of Site master file and validation master plan
• Review of audit trials for GXP systems
• Preparation and review of Quality trends like Incidents, Market complaints and CAPAs
• Review of process validation protocols/reports, cleaning validation protocols / reports, executed batch records, stability protocols, submission of batch protocols/report, Continuous process verification protocols/reports, Confirmatory/Trial/Pre-validation protocols/ Reports and miscellaneous protocols/ reports
• Handling of market complaints and product recalls
• Initiation of incidents, review and approval of incidents
• Review and approval of the investigations of 1B incidents in absence of reporting manager
• Review and approval of all validation / qualification protocols and reports with respect to FAT/DQ/SAT/IQ/OQ/PQ/SLIA/PSQP for facility, area, equipment and utilities
• Coordinate and participate in preparation of risk assessment for all new/existing (Subjected to any change) equipment’s/systems/utilities/process
• Review of Pest and rodent control records and time synchronization records of equipment
• Review of all documents related to GxP systems used for GMP operations / activities
• Verification of vendors/third party (Service provider) contract agreement those are required for performing calibrations on specific instruments/Equipment's on/off site
• Organization and co-ordination of QRM activity related to site and Global quality
• Participation of validation activities to ensure compliance to approval protocol

Educational qualification: A master degree in Pharmacy, Pharmaceutical Sciences, or a related field; 

Minimum work experience: 4-5 years of experience in the pharmaceutical industry, with a focus on quality management and Engineering assurance.

Skills & attributes:
Technical Skills
• Thorough understanding on Handling of QMS events, Self-Inspection management, Investigation report review, Preparation and review of APQR.
• Experience in review and approval of all qualification/Validation activities.
• Expertise in conducting, reviewing, and approving risk assessments.
• Strong focus on ensuring data integrity and compliance with documentation standards.
Behavioural skills
• Effective communication skills to relay SOP changes and ensure understanding across cross-functional teams.
• Meticulous attention to detail for reviewing all documentation activities.

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/#!/

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