Team Member - QA Validation

Dr. Reddy's Laboratories; Srikakulam; On-site; INR 1,200,000 - 2,400,000; Full time

Benefits offered by this job

Relocation support

Maternity & paternity benefits

Medical coverage for family

Life insurance

Job summary

Dr. Reddy’s Laboratories Ltd. is seeking an experienced professional for the Quality Assurance investigations role. You will review qualification protocols, manage change controls, and participate in investigations of incidents and deviations.

The position demands 5 to 10 years in a pharmaceutical setting, with a focus on QA, documentation, and compliance across GMP processes. On-site location in India with opportunities for growth and professional development.

Qualifications

• Bachelor's or Master's degree in Pharmacy is required.
• 5–10 years of experience in pharma or related industry with focus on investigations and quality assurance.

Responsibilities

• Review qualification protocols and reports for facility, area, equipment, and utilities.
• Review and approve smoke study protocol and report.
• Review VMP and requalification calendar for equipment, facility, and utilities.
• Handle and closure of quality management system including change controls, incidents, and CAPA.
• Participate in investigations triggered by incidents or deviations.
• Prepare and review SOPs as required.

Skills

Quality Assurance

Investigations

Documentation

Education

Bachelor's/Master's in Pharmacy

Tools

DocHub

e-VAL

SAP DocuSign

Job description

Job Description:

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

Roles & Responsibilities

• Review of qualification protocols and reports of facility, area, equipment, and utilities including URS, DQ/FS, RA, SLIA, Project specific qualification plan, commissioning checklist, IQ, OQ, UTM, PQ & RQ.
• Review and approval of smoke study protocol & report.
• Review of VMP and their subsequent revisions.
• Review of VMP re-qualification calendar for all equipment, facility, Utility etc.
• Review of PMP check list/schedules and Master calibration andFacility maintenanceplanner etc.
• Review of Audit trails, master instruments calibration certificates.
• Review of logbooks for its compliance and good documentation practices.
• Ensuring compliance to VMP revalidation schedule as per revalidation matrix for all equipment, facility, utility etc.
• Allotment of numbering for equipment’s, area, layouts and to prepare / Update the List.
• Handling and closure of quality management system which includes change controls, incidents & CAPA.
• Participation in investigations that are triggered due to incidents/deviations as applicable.
• Responsible for preparation, review of SOP as per requirement.
• Review of BMS & EMS related documents and alarms & audit trials reports for its compliance.
• Review of activity related to critical equipment breakdown notification.
• Review of equipment breakdown and general maintenance notification.
• Compilation and Preparation of Annual review of utilities reports.
• To perform GEMBA walk in utility system i.e. HVAC, compressed air, and water system, etc.
• Review of Pure steam quality reports, compressed air and nitrogen gas testing reports.
• Review of documents in DocHub, e-VAL, SAP DocuSign as applicable.
• Review of cleaning validation protocols and reports.

Qualifications

Educational Qualification

A Bachelor's or Master's degree in Pharmacy,

Minimum Work Experience

5 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance

Additional Information

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. 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/#!/

• Job Family: Quality
• Sub Job Family: Quality Assurance
• Preferred type of working: On-Premise
• Business unit: GMO

Requirements: