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 Summary**

**Roles & Responsibilities**
- You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents.
- Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems.
- You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test).
- You will review and compile raw data, relevant certificates, analysis test reports and
- preparation and review of final summary report.
- You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation.
- Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval.
- You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification.
- As part of your role, you will prepare and review VMP (Validation Master Plan).
- You will conduct training for employees and external vendors as a qualified trainer.
- Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label.
- You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment.
- You will also provide necessary assistance and support to various regulatory, internal and external inspections.

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

**Minimum work experience**: 3 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 Organisa

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