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Executive

Cadila Pharmaceuticals Limited

0 years

0 Lacs

Dholka Gujarat India

Posted:1 day ago| Platform:

Apply

Skills Required

technology manufacturing development support compliance management sampling report stability resolve

Work Mode

On-site

Job Type

Full Time

Job Description

To perform the technology receiving activities and QMS related activities at the manufacturing plant.
To perform technology-receiving activities by receiving processes from upstream process development to manufacturing and/or between multiple manufacturing sites. This includes developing and maintaining key SOPs, manufacturing records to support compliance with quality management and regulatory submissions.
To perform alternate vendor batch execution, process improvement, change in batch size, trouble shooting at shop floor, equipment change activities of product after technology transfer completion along with production team.
To coordinate the development of the manufacturing process with the R&D by keeping in mind scale-up issues, process specifications, and operating procedures for new products, new equipment, and technologies for successful product receiving.
Work out on finalizing batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production.
To prepare/review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches.
To provide technical support for change management, investigations of deviations or OOS, CAPA identification and QMS related activities at plant.
To provide technical support for CMC section of ANDA submissions or other regulatory agency documents prior to forwarding to the Regulatory Affairs for inclusion in the supplement submission. Principal task and responsibilities:
Ensure cGMP and Regulatory compliance.
To cross check the online documents periodically to ensure the good document practice.
To rectify any activity which is making adverse effect on productivity or quality, in consultation with QA Department.
To ensure discipline from co-workers and get systematic work to improve quality.
Arrange CFT meeting to resolve day to day issues.
Involve in closure of change control note, deviation and give guidance to ensure that it is complete in time.

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Cadila Pharmaceuticals Limited

Pharmaceuticals

Ahmedabad

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