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35 Ipca Laboratories Jobs

Lab QA Officer

1-2 years

West District

1 vacancy

Lab QA Officer

Ipca Laboratories

posted 18d ago

Job Role Insights

Flexible timing

Key skills for the job

Job Description

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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What people at Ipca Laboratories are saying

What Ipca Laboratories employees are saying about work life

based on 2.8k employees
54%
67%
43%
97%
Flexible timing
Monday to Saturday
No travel
Day Shift
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Ipca Laboratories Benefits

Job Training
Soft Skill Training
Free Transport
Health Insurance
Cafeteria
Team Outings +6 more
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