Posted:1 day ago|
Platform:
Work from Office
Full Time
1.Responsible for work planning and review of documents related to In process, DS, DP, stability testing, AMV and AMT activities within quality control laboratory.
2. To effectively plan and monitor shift duties of the QC analytical staff members to support 24*7 business operations.
3. Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines.
4. Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnels and evaluation of effectiveness.
5. Responsible for the periodic assessments/audits to identify gaps / improvement opportunities for strengthening the quality & regulatory compliance. Prepare remediation/mitigation plan (CAPA) and execute it in a timely manner by coordinating cross functionally to uplift the level of compliance’s.
6. Responsible for review and approval of documentation such as SOP’s, Specifications, STP’s, TDS, reports for IRS analyst qualification, protocols, Qualifications and reports etc.
7. Responsible for investigations and approval of OOS, OOT and deviations. To recommend and approve CAPA, change controls.
8. To release or reject the samples handled in quality control laboratory.
Enzene
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