Established in 1984, Dr. Reddy’s Laboratories is an emerging global pharmaceutical company.
As a fully integrated pharmaceutical company, our purpose is to provide affordable and innovative medicines through our three core businesses:
- Pharmaceutical Services and Active Ingredients, comprising our Active Pharmaceuticals and Custom Pharmaceuticals businesses;
- Global Generics, which includes branded and unbranded generics; and
- Proprietary Products, which includes New Chemical Entities (NCEs), Differentiated Formulations, and Generic Biopharmaceuticals.
Our products are marketed globally, with a focus on India, US, Europe and Russia. Dr. Reddy’s conducts NCE research in the areas of metabolic disorders, cardiovascular indications, anti-infectives and inflammation.
Job Title : SME - Microbiology
Job Description :
- Facilitate setting up systems and controls for set up, operation and maintenance of a manufacturing set up for manufacture of solid orals, ointments, creams and sterile.
- Provide guidance from a microbiological perspective on new set up or to changes to the existing set up in line with the regulatory expectations and industry standards.
- Provide guidance in designing control and assurance systems towards to ensure compliance with cGMP and lab practices in manufacturing, testing, release, holding and distribution of drug products.
- Provide training to the staff involved in practices that can have microbiological significance.
- Audit the existing systems and propose measures to correct the gaps in line with the regulatory expectations.
- Upfront identify changes to the regulatory environment with regard to microbiological changes areas and their requirements and implement the changes.
- Support to develop structured investigation processes related to Microbiology so as to bring about a logical conclusion to the investigation.
- Put practices in place for effective management of utilities like water and environment.
- Develop KPI and monitor the health of the set up and update management in a periodic frequency
- Develop and pick up trends for water, environment, and other relevant utilities during routine operations at the sites and propose corrective and preventive measures.
- Develop team members to learn, propagate and support the improvement process.
Desired Profile :
Education (minimum/desirable) : M.ScMicrobiology / PhDMicrobiology
- Reduce micro related incidents to near Zero
- Compliance to standards
- Reduction in Testing errors
- Setting up of right SOPs
Skill Set :
- Broad Knowledge of Regulatory requirements
- In-depth knowledge of Injectable / Ointment laboratory requirements with knowledge of sterile manufacturing and controls (all core areas)
- Detailed understanding of microorganisms and their impact on patient safety
- Detailed understanding of qualifications and method / process validations
Languages :
- Good knowledge of English
- Knowledge and Exposure
How to Apply :
Interested candidates can apply online sing the link below :
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