Manager - Qualification & Validation (Sterile)

Immacule Life Sciences

12 - 16 years

15 - 18 Lacs

nalagarh

Posted:-1 days ago| Platform:

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Skills Required

validation protocol quality assurance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Responsible for maintaining the validation documents and validation planner.
Preparation of Standard Operating procedure related to Qualification.
Preparation of protocol, execution and compilation of aseptic process simulation report.
Responsible for preparation review, approval and control of effective documents.
To ensure compliance of GDP and data integrity techniques.
To follow EHS policies.
Responsible for Online activities in ERP, LMS, EQMS, LIMS, and EDCS, Caliber BMR as per requirement.
Responsible for initiation/ closure of Quality Management System (QMS) related documents: Change Control, Deviation, Incident, and CAPA in EQMS as per requirement.
Co ordination with cross functional team and external party to execute the validation activities.
To handle the QMS activities related to qualification and validation.
Responsible to impart the training and department training coordinator activity.
Responsible for aseptic assurance.
Media fill protocol preparation review and approval.
Smoke study protocol preparation, review and approval.

Preferred candidate profile

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