Operation Manager at Autonomy
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Manager - Quality Control - Pharma (10-12 yrs)
We have career opportunity as Manager QC with leading pharma company at Sachana,Gujarat.
Qualification : Bachelor of Science, M.sc, B.pharma, M.pharma
Description :
1. Responsible for over all management of laboratory functions and compliance to applicable standard.
2. To review and release of RM / FG/ PM/SFG as per approved specification.
3. To reviewed and approve analytical reports, validation protocol, calibration reports.
4. Preparation and review of department sops.
5. To ensure instrument are calibrated timely and review of record.
6. To ensure compliance of laboratory instrument and lab - compliance of 21 CFR 210, 211 EU GMP and other applicable GMP, GDP.
7. Management review of product Quality, QMS and continue improvement plan.
8. OOS/incident/OOT/deviation and CAPA / impact assessment plan.
9. Experience on sterile products, injection, LVP, SVP, lyophilized, dry powder, tablets, ointments. Exposure of Injectable Range is Mandatory.
10. Hands on experience / trouble shooting in chemical testing HPLC, GC, AAS and all QMS related activities.
11. Having an exposure of all type of analysis on sophisticated instruments like HPLC, GC, FTIR, UV, TOC, Karl Fisher, Polari meter, FTIR, Dissolution, Friability, DT, Auto titrator and other instruments.
12. Co-ordination with plant to reduce the break down time and increase the productivity without delaying results and train team members for new method and update the technical and soft skills.
13. Handling scheduled visits, audits and inspection from internal as well as external audit agencies like WHO- GMP & US FDA, EU-GMP audits. Managing timely completion of compliance of various audits and inspections, routine communication to corporate and customers.
14. Must have current experience of both routine and non-routine
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