1) Preparation, execution and review of various qualification protocols and ensuring completion of protocol and report.
2) Coordination with calibration activities and compliance of calibration schedule.
3) Verification and compliance of Preventive maintenance schedule.
4) Responsible for preparation, issuance & review of Master BPR, Master BMR.
5) Preparation & review of APR.
6) Responsible for document control, records retention.
7) Preparation, review, distribution of Standard Operating Procedure.
8) Handling of on line rejection of Raw & Packing material.
9) Taking rounds in process area and reporting observations to QA Head.
Validation & In-Process Quality Assurance:
1) Organizing and conducting the validation activities
2) Responsible to Sampling of Validation batches as per protocol & filing of validation protocol during batch Manufacturing & Packing.
3) Responsible for In-process checks during manufacturing (Granulation, Compression & Coating) &packing, to give the line clearance for start of activity in production & stores area.
4) To collect the in process, finished product & control samples.
5) Maintenance of control samples & documentsrelated to control samples
We are looking for appropriately qualified candidates with 3 to 6 years of relevant in Quality Assurance with a regulated Pharma company should have exposure in all sophisticated Quality Assurance.
Experience: 3-6 Years
Education: B.Pharma, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality Assurance
Salary: 2 – 4 Lacs per annum
End Date: 1stDecember 2016
Forward your resume at, email@example.com