Dr Reddy's - Director - Microbiology

1.0 Responsibility

1.11 To formulate systems and controls for set up, operation and maintenance of a manufacturing set up for manufacture of solid orals, ointments, creams and sterile.

1.12 To 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.

1.13 To 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 .

1.14 To provide training to the staff involved in practices that can have microbiological significance.

1.15 To audit the existing systems and propose measures to correct the gaps in line with the regulatory expectations.

1.16 To upfront identify changes to the regulatory environment with regard to microbiological changes areas and their requirements and implement the changes.

1.17 To support to develop structured investigation processes related to microbiology so as to bring about a logical conclusion to the investigation .

1.18 To put practices in place for effective management of utilities like water and environment.

1.19 To develop KPI and monitor the health of the set up and update management in a periodic frequency

1.20 To develop and pick up trends for water, environment, and other relevant utilities during routine operations at the sites and propose corrective and preventive measures.

1.21 To develop team members to learn, propagate and support the improvement process

Education Qualifications :

- An academic background in pharma / medicine and a post graduate degree in Microbilogy are necessary.

- A minimum of 18 years experience in pharma industry .