20 AGIO Pharmaceuticals Jobs
IPQA Head
AGIO Pharmaceuticals
posted 2hr ago
Fixed timing
Role & responsibilities
1.
The principle and guideline of Good Manufacturing Practices were followed during Manufacturing
2.Responsible for shop floor activities including in manufacturing and packing
3.To co-ordinate with other department like Warehouse, Engineering, QC and Rand D to complete the work without any delay
4.Management of Data Soft and track trace system.
5.Control sample room management.
6.Ensure the withdrawal of in process sample for testing and finished product sample for finished product testing, stability testing and control samples.
7.Responsible for, review of BMR and BPR, release or rejection of finished product for dispatch as per site SOP and to investigate if the batch does not meet the specification or any discrepancy
8.Handling of Transport validation and Investigation of any excursion or damage during transportation
9.Approval of Bill of Process (BOP of RM &PM) in ERP system
10.Review and approval of APQR and escalation of negative trend for improvements.
11.Ensure the withdrawal of sample for process validation and cleaning validation
12.Ensure the Implementation and Adherence to cGMP requirements during manufacturing of product.
13Responsible for archival executed batch records document (BMR, BPR and QC data of respective batch) to document room
14Responsible for any other work allocated by the Head QA.
Preferred candidate profile Candidates preferred from reputed pharma background
Employment Type: Full Time, Permanent
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