25 Biological E Jobs

1) To lead a team of MES and maintain the compliance philosophy. To upgrade the system as per the requirements

2) Perform the activity in accordance with current version of SOP.

3) Ensure timely complete trainings.

4) Participate in master data management, backup, archival and maintenance of MES.

5) Preparation and revision of recipes for MES system based on current BMR/BPR/Documents.

6) Responsible for preparation, review and execution of departmental SOPs

7) Support in resolution of MES issues identified during manufacturing and escalate the same as required

8) Coordinate and support the CFT for smooth execution of MES activities.

9) Ensure the completeness of documentation for all performed activities.

10) Adherence to safety procedures/GMP & GDP practices.

11) Ensure compliance of operations to cGMP, safety and BE integrity principles at all stages of activity.

12) To participate in internal & external (Regulatory& Non-Regulatory) audits.

13) Develop principles as cGMP, Regulatory guidelines, data integrity management practices

14) To attend the training of all applicable procedures as per schedule and getting trained on respective area of work.

15) Ensure all QMS tools (change control, deviation management and CAPAs) are appropriately tracked & completed within the target timeline.