Overview
Manager Analytical Quality Assurance Jobs in Baddi, India at Acme Generics
Location: Baddi
Responsibilities –
Handling of overall Analytical Quality Assurance activities.
Handling, review, approval and closure of Quality management system Documents related to Quality control
Deputed as Single point of contact for all the submission related activities such as Dossier submission, Regulatory submission or variation filling activities.
Responsible as Single point of contact for customer communications.
Review of submission or validation batch documents of manufacturing, packing and analytical reports.
Review of Stability data & submission.
To ensure the compliance of stability studies handled at site.
To ensure the compliance of control samples handling at the site
To ensure monitoring of compliance with the requirements of GDP/GLP.
To ensure the Gowning/ De-gowning procedure to be followed during Entry/ Exit of Quality Control Lab.
To ensure authorization of written procedures and other documents, including amendment.
To ensure compliance of work in all sections like Raw material/Packing material, Finished goods, Inprocess, Analytical Method Validation, Process Validation, Stability Technology transfer outside testing laboratory to all section and Microbiology Section HB.
Verification of practice versus documentation, on line entries of analytical activities in respective logs and analytical reports.
To ensure that logbooks and all other documents related to QC are in compliance
To ensure that the procedure followed as per SOPs and approved protocol.
Responsible for management of quality agreement and its compliance.
Handling, review and approve the investigation of OOS/OOT, Incident, deviation, change control at quality assurance level.
All time readiness for QC.
To verify schedule ,approval documents of calibration ,validation ,preventive maintenance ,qualification
Title: Manager Analytical Quality Assurance
Company: Acme Generics
Location: Baddi, India
Category: Quality Assurance – QA/QC, Healthcare
