Team Member Cip Avd

6 months ago

Hyderabad Telangana, 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 review of proposed vendor tech pack for APIs & Excipients and identifying potential impact on drug product manufacturing process and specifications and testing methods.
- You will be responsible for collection and review of existing trend data of API (Active Pharmaceutical Ingredient) and formulation, identification of Critical Material Attributes (CMAs), Critical Process Parameters (CPPs) and impact of CPPs on Critical Quality Attributes (CQAs).
- You will develop strategy for proposed vendor material assessment based on inputs from the review of tech pack and formulation trend data, and coordinating with sourcing team for procuring the required materials.
- You will be responsible for preparation of Material Assessment Report and other master documents like submission/validation protocols and reports, hold time study protocols/reports, Stability protocols, Equivalency reports, Justification reports, etc.
- You will be responsible for execution of scale-up, Exhibit and Validation batches at respective manufacturing units.
- You will be responsible for initiation of quality notifications like incidents, change controls, etc.
- You will investigate Out of trend and Out of specification results through root cause analysis.
- You will co-ordinate with cross functional teams for execution of feasibility trials, exhibit batches or validation batches.
- You will be responsible for development of new products for India & Emerging markets, which includes activities like Literature search, Selection of right excipients, Pre-formulation studies, product & process development using QBD/DOE principles, process optimization through execution of scale up batches, execution of exhibit batches, generating data required for variation filing, responding to regulatory deficiencies and successful implementation at commercial scale after approval.

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

**Minimum work experience**: 2 to 5 years

**Skills & attributes**:
***
**Technical Skills**
- Expertise in the development of Oral Solid Dosage (OSD) formulations, knowledge of formulation processes and technologies, and Knowledge of process validation and optimization.
- Experience in the development and assessment of alternate vendors, and understanding of vendor qualification processes.
- Successful execution of technology transfer processes for Oral Solid Dosage formulations.
- Expertise in identifying Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs), ensuring compliance with regulatory and quality requirements, conducting vendor material evaluation, and functionality testing.

**Behavioural Skills**
- Effective communication and collaboration skills.
- Critical thinking and problem-solving skills for investigations and process optimization.
- Attention to detail for documentation and regulatory compliance.

**Additional Information** About the Department**
**Global Manufacturing Organi

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