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Intas
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Executive/Sr. Executive - Quality Assurance (IPQA)

Executive/Sr. Executive - Quality Assurance (IPQA)

Intas

2 - 7 years

2 - 6 Lacs

ahmedabad

Posted:2 weeks ago| Platform:

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Skills Required

ipqa process validation quality assurance cleaning validation bpr review injectables risk assessment capa pharmaceutical quality control bpr production sampling change control production operations lims oos sop oot qms mfr

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilites

1.In process Quality Assurance activity in Production and warehouse area

2.Provide line clearance as per SOP

3.Monitoring and QA rounds in production and Warehouse

4.Sample verification against TRF / BPCR

5.Carry out Semi-finished / finished product sampling for release, stability study and control samples

6.To send samples along with TRF to Quality control laboratory

7.Participate in media fill, process validation, cleaning validation activities as per requirement

8.Timely communication and co-ordination with all the stake holders

9.Participation in Change control, Deviation & Investigations as per requirement

10.Preparation / review of documents like; SOPs, risk assessment report and any other document as per requirement

11.Timely review of Batch Process & Control Records, Validation protocol / reports, Calibration, Qualification protocol / reports & Trend analysis data

12.Timely review of executed batch records and associated data

13.Keep vigilance on production operations

14.Review of Analytical Reports as per requirements

15.Participation in Audits & Compliance activity

16.In addition of above, any other responsibility assigned by Superior / HOD

17.Final release of critical intermediate and drug substance batches in LIMS and SAP

18.Risk assessment preparation and review

19.Draft MFR/BPCR/BPR review

Qualification Required

B. Pharm / M. Pharm

Relevant skills / Industry experience

2-10 Years with Injectables or Biotech Induastry in IPQA department

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Pharmaceuticals

Ahmedabad

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Executive/Sr. Executive - Quality Assurance (IPQA)