Greetings from Global Calcium!!
We have multiple openings in QA for below JDs,
Looking out for candidates with experience in API pharma industries only
Refer below JDs and if interested share resume to ezhil.m@globalcalciumpharma.com with below details,
1. Total experience in API:
2. Current CTC:
Validation QA:
- Experience in process validation, cleaning validation and API production process.
- Experience in equipment and utility qualification.
- Preparation and Revision of MFR for all new existing products on changes.
- Review of LMR & BPR for all new or existing products based on changes.
- Experience in Quality management system e.g. Change control, deviation, market complaint and process technology transfer from R&D to production.
- Candidate should be from USFDA, EDQM approved API organisation
AQA :
1. Experience in QC activities i.e. Analysis of API (Wet and instrument)
2. Calibration of critical analytical instrument i.e. HPLC, GC. ICP-OES,IC, AAS, LC-MS, Stability Chamber etc.
3. Experience in method validation e.g. in related substance, assay content, elemental impurities as per regulatory guideline (ICH)
4. Experience in preparation, reviewal and approval QC document i.e. specification, test method, analytical test report, stability study report and method validation report.
5. Knowledge of General chapter requirement as per monograph. E.g. USP, BP,EP, IP
6. Knowledge of review and approval of computer system validation report of analytical instrument as per 21 CFR Part II requirement or GAMP5 requirement.
7. Experience in reviewing and approval of QMS document related to QC i.e. OOS, OOT, Change control, Deviation, Laboratory incident.
8. Experience in reviewing and approval of analytical instrument audit trail as applicable. (HPLC, GC, ICP-OES,IC, AAS. LC-MS)
9. Experience in handling of customer audit and expose to regulatory audit will be preparable.
QMS:
1. Receipt, login, review, co-ordination, follow-ups with respective department and tracking of Change management, edit forms with impact assessment and implementation effectiveness.
2. Receipt, login, review, co-ordination, follow-ups with respective department and tracking of Deviation management, Laboratory incidents with implementation of CAPA.
3. Handling of OOSs, incident and OOTs through detailed investigations to establish suitable CAPA.
4. Coordination on Customer compliants and Customer Returns investigation and relevant CAPA.
5. Preparation and Review of Product Quality Review.
6. Co-ordination in CAPA.
7. Co-ordination with Purchase/ Marketing to fix the Vendor Audit and conducting vendor Audits, relevant CAPA compliance and Implementation.
8. Review of vendor questionnaires and co-ordination in vendor qualification.
9. Co-ordination on Audit related activities and relevant documents.
10. Document Management control.
IPQA:
1.To ensure line clearance in all plants
2.Inprocess QA Checks
3. Coordination for despatch clearance
4. Preparation and review of LMR/ BPR
5. To verify the stability chamber working status on daily basis
6.Daily visit to engineering area- purified water plant and verification
7.Checking of routine records, log books, online LMRs, etc.,
8. Monitoring of sampling by QC/ Microbiology
9. To ensure pest control documents
10. To issue the under test labels, cable ties and anchor locks.
11. Document management and control
12. Coordination with engineering during AHU and equipment qualification
13.Coordination in preparation of APQR
14. Preparation of MFR
15.Preparation of process validation protocol and reports
16. Coordination for utility validations, qualification activity and documentation
17. Periodic verification of calibration & preventive maintenance program and checking of reports
18. Coordination with engineering team for preparation of protocol and report compilation of temperature mapping activity.
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