Dr Reddy's - Director - Sterile

1.0 Responsibility

1.1 To formulate systems and controls for set up, operation and maintenance of a Sterile manufacturing set up

1.2 To provide guidance on new sterile set up or to changes to the existing set up in line with the regulatory expectations and industry standards.

1.3 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 .

1.4 To provide training to the staff involved in Sterile and related activities.

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

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

1.7 To support to develop structured investigation processes related to sterile so as to bring about a logical conclusion to the investigation

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

1.9 To pick up trends during routine operations at the sites and propose corrective and preventive measures.

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

Education Qualification :

1. M.Sc / Pharma graduate with 18 - 22 Years of relevant pharma experience