35 Ipca Laboratories Jobs
Lab QA Officer
Ipca Laboratories
posted 18d ago
Candidate Must have experience in QC department.
Responsibility
Batch Record Compliance
1. Responsible for Issuance, Checked & Review of BMR/ BPR
2. Responsible for Review, Check and Approval of Bill of Material in RM & BMR /
BPR of in SCM.
3. Responsible for Technology Transfer Document of analytical & manufacturing
Process Related.
4. Responsible for review of filled BMR/BPR & Logbook.
QMS Compliance
1 Responsible for handling of Deviation, CCP, CAPA, & Market Complaints.
2 Responsible for Self-inspection and ensuring their CAPA are taken along with
Their implement
3 Update of Price List and Shelf Life as per the Procedure.
Batch Release System
1 Responsible for Batch Release System as per the Procedure:-Final, Quarantine
and Partial Release.
SOP Management
1 Responsible for preparation of Standard Operating Procedure.
2 Responsible for Review, Control, Issuance and Retrieval of Standard Operating
Procedure.
3 Responsible for Gap Assessment / Unit Operation of Area SOPs.
PQR / APQR Compliance
1 Responsible for APQR/ PQR data compilation & its preparation.
2 Responsible for Review of PQR / APQR.
Manufacturing Control
1 Responsible for Dispensing Activity, Line Clearance in Manufacturing activity
and Packing activity.
2 Responsible for the collection of in process sample, Validation sample, Stability
sample, Hold time Sample and Control sample.
3 Handling of various instruments at IPQA lab for testing of various types of
sample.
4 Responsible for Raising Shop floor activity (i.e. Six System observation and its
Compliance for effective closure.
5 Responsible for Taking Wash Water Sample and its Analysis.
Legal Compliance
1 Responsible for Application & Renewal of Product Permission.
2 Responsible for Application & Renewal of Various Certificate i.e. Schedule M
GMP, GLP & WHO.
3 Responsible for Application & Renewal of Certificate of Pharmaceutical Product.
4 Responsible for Application & Renewal of Various Certificate i.e. Manufacturing
& Marketing Certificate, Capacity & Quality Certificate, Performance Certificate,
Production Certificate, non Conviction Certificate as per requirement and
Queries with CDSCO
5 Responsible for Any Communication with respect to Pharmacopoeial
Compliance, Audit Response, use of Controlled Substance, etc.
Validation/Qualification Activity
1 Responsible for Preparation of validation protocol.
2 Responsible for Handling of Validation/ Qualification activity
3 Responsible for Preparation, Execution of equipment Qualification, Protocol &
Report.
Training Management
1 Responsible for Training of Staff and Schedule Training.
Stability Compliance
1 Responsible for Review of COA / TDS of Stability Sample.
2 Responsible for CAPA implementation during OOS / OOT / Lab incident.
3 Responsible for NCR related Investigation and its logging.
4 Responsible for preparation of trend related to OOS, Lab incident and OOT
along with its related CAPA.
5 Responsible for withdrawal of stability samples as per the monthly withdrawal
schedule and updation of same in all the relevant logs and format.
6 Responsible for Stability Study Chamber Management .
7 Compilation of stability reports after preparation of Stability Study Release.
Lab QA Compliance
1 Responsible for Review of COA / TDS of Raw Materials, Packing Materials,
Finished Product.
2 Responsible for Handling of OOS, OOT & Lab Incident.
3 Responsible for Investigation of OOS, OOT & Lab Incident.
4 Responsible for Review of QC reports(in process, finished)
Control Sample Compliance
1 Responsible for Management of Control Sample.
2 Responsible for Physical Verification of Control Sample.
3 Responsible for Verification of logbook in Control Sample area.
4 Responsible for Destruction of Expired Sample after Physical Verification.
RFT Compliance
1 Responsible for Review of QMS Area & logbook on daily basis.
2 Responsible for online entry in logbook.
3 Responsible for review of Adequate supporting documents for the closure of
QMS Documents.
Employment Type: Full Time, Permanent
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