Specialist, Quality Assurance

Vantive

3 - 6 years

5 - 8 Lacs

gurugram

Posted:None| Platform:

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Skills Required

training manager quality assurance compliance finance standard operating procedures internal quality auditor data integrity gmp recruitment auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

To perform internal quality audits to ensure compliance to all systems and procedures and ultimately build the quality focus and ensure appropriate CAPA is placed.
To ensure that system and facilities comply as per the regulatory requirements and expectations.
To ensure cGMP compliance status of site as per regulatory requirements.
To ensure and sustain all time ready plant in line with current regulatory expectations for regulatory authorities and other partner inspection.
To verify process and systems are complying with standard operating procedures (SOPs) and current regulatory requirements and expectations.
To ensure that audit observation compliance and effectiveness of CAPA.
To perform review of operations and report in case of any non-conformance observed.
To perform periodic assessment of the GMP trends.
To perform the assessment of regulatory intelligence program and global observation certification.
To ensure that the required initial and continuing training of personnel is carried out and adapted according to need.
To impart training to personnel regarding enhancement in system, and processes.
To handle electronic QMS modules for review and approval of changes, procedures etc.
To ensure that data integrity is maintained at all level and to perform / get performed regular checks to ensure that system is in state of control.
Support product surveillance team in coordinating with Marketing team for sample submission issues or any other unresolved issues.
Coordinate with sales and marketing team if any significant issues arise.
Trending of significant issues and escalation, evaluating issues and working out for various actions.

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