Team Member Qualification

2 weeks ago


Andhra Pradesh, India Dr Reddy's Laboratories Limited Full time

**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**

**Roles & Responsibilities**
- Must be aware of cleanroom practices, and behavior.
- Experience in sterile manufacturing equipment qualification is mandatory.
- Preparation and Execution of qualification protocols for Equipment’s, Autoclave, Tunnel, Filling and capping machine, Lyophilizer, Washing machine, bung processor etc.
- Preparation and Execution of qualification protocols for HVAC system.
- Review of HVAC designs documents, understand on RDS and all layouts of HVAC.
- Review of Utilities (WFI, PW, Compressed air, Nitrogen) designs documents like DQ, P &Id, process schematics, as built drawings etc.
- Preparation, review and execution of DQ, FDS, UTM.
- Preparation, review and execution of SAT, IQ, OQ, PQ documents (protocols and reports).
- Preparation and review of Risk assessment of equipment’s / systems.
- Review & compilation of raw data, relevant certificates, analysis test reports and preparation and review of final summary reports.
- Must follow GDP and ALCOA in all documentation, execution activities and compliance to 21CFR.
- Preparation, review and execution of SAT, IQ, OQ, PQ documents for Packing and inspection equipment’s (protocols and reports).

**Qualifications**
**Educational qualification**:An M.Pharm.

**Minimum work experience**: 5+ years of experience

**Skills & attributes**:
***
**Technical Skills**
- Experience in working with sterile product facility related validations such as equipment validation, media fill, cleaning validation, process validation, area qualification, and other miscellaneous qualifications.
- Expertise in preparation, review, and execution of documents, including URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ.
- Experience in Handling incident investigations and CAPA processes.
- Experience in preparation and review of VMP and SOPs.

**Behavioural Skills**
- Effective communication skills for conducting training sessions and qualification activities.
- Attention to detail for preparing and reviewing documentation and reporting.
- Application of problem-solving skills in incident investigations and CAPA implementation.
- Efficient time management for meeting qualification schedules.

**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



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