Acme Generics | Manager

2 weeks ago

himachal pradesh, India Acme Generics Full time
Responsibilities
Responsible to ensure cGMP compliance in the departments and site.
Responsible for review of audit observation, its compliance and report preparation and approval and closure with client approval.
Responsible to ensure the preparation, scheduling & conducting self-inspection audits & compilation of reports.
Responsible for water system validation, HVAC, compressed air, facility, CSV and utility validation etc.
Responsible to impart training on departmental SOPs, GMP, GDP, GLP & GXP and training compliance across the site.
Responsible for review and approval of the process validation protocol & report and ensure effective execution of process validation activities.
Responsible for review and approval of the Hold time study protocol & report and ensure effective execution of Hold time activities.
Responsible for review and authorization of Standard Operating Procedure of all departments.
Responsible to ensure the Qualification and Re-qualification of the Equipment/Instruments, facility and system.
Responsible to ensure work discipline in the department.
Responsible for quality agreement and its compliance.
Responsible for review of all apex documents.
Responsible for Liasoning related documents like product approval, COPP, Free sale certificate, Renewal of manufacturing license and GMP Certificates etc.
Responsible for the acknowledgment of the received market complaint and approval on the categorization of market complaints. To participate in the review and approval of the investigation report of the Market Complaints.
Responsible for review and approval of the work related to Quality Management System.
Responsible for Coordination with clients for Technology Transfer.
Responsible for Coordination with different departments/Sites for submission of required documentation to different clients in timely manner.
Responsible for the management for approval and release of the batch.
Responsible for review and approve specification, Standard Test procedure (STP)and General Test Procedures (GTP) & etc. of Quality Control Department.

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