JOB DESCRIPTION:
Followings will be the responsibilities of the position holder:
- To Prepare, Review and approval of Process Validation, hold time and cleaning validation Protocol and Reports for oral dosage facility.
- To perform Technology Transfer Data Package review.
- To assess and the New Products Internalization / Externalization activities.
- To Prepare and review of SOPs in Darius.
- Review of Change controls related to new products, Product transfers and changes in process.
- To execute assigned tasks in SolTRAQs related to Change control and Exception etc. for ODF.
- To carry out self-inspection as per assigned schedule.
- To ensure self-training in ISOtrain within stipulated time and impart training to subordinates/cross functional team as per schedule.
- To ensure compliance of current Good Manufacturing Practices in the Oral dosage facility & to follow GDP with data-integrity compliance.
In absence of the position holder, Manager working in section or the authorized designee shall be responsible for day to day working.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
India > Village Mauza : Baddi
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)