Executive QA

Sun Pharma

4 - 6 years

5 - 6 Lacs

bengaluru

Posted:-1 days ago| Platform:

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Skills Required

compliance for quality control review of specification and periodic review of water gmp compliance review of analytical records stp

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles :

To ensure GMP compliance to approved procedures / practices as per SOP.
Responsible for review of analytical records, handling of QMS related activities for Quality control.
Ensure compliance for Quality Control (Analytical, Bioassay and Microbiology sections).
Review of Specifications & STPs related to Quality Control department.
Compliance verification in Quality control department by frequent lab visits.
To ensure compliance to Retention/control sample management and document cell management in line with SOP for retention, destruction and withdrawals.
Periodic review of Water & EMP trends and escalation if any abnormalities/OOT/OOS observed.
Preparation, Review of stability schedules, summary reports with relevant Raw data sheets.
Issuance, Control & Archival of documents.
To have understanding and managing the Training related activities of On-boarding, On-Job and other modes to maintain the Lab, other applicable areas against Job roles.Tracking and reporting any abnormalities, escalating to hierarchy to comply as per the SOP/s.
Any other work assigned by the section Supervisor / in-charge / Head of the Department QA/Quality.

Responsibilities:

Responsible for review of analytical records, handling of EDAMS, LMS, QMS /EDMS related activities for Quality Assurance, Quality control, Internal Audit observations and compliance for Quality Control.
GMP/GLP rounds as part of periodic Lab and routine facility maintenance / assurance on EM / Water monitoring in order to ensure the product SISPQ (Safety, Identity, Strength, Purity & Quality) while batch review / release through a proper tracking mechanism in place.
Review of process technical / regulatory documents, coordinating with SMEs and assisting to the HOD.

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