Corporate Quality Assurance

Rusan Pharma

8 - 13 years

4 - 9 Lacs

Mumbai Mumbai Suburban Mumbai (All Areas)

Posted:1 month ago| Platform:

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Skills Required

QMS Vendor Qualification Capa Change Control OOS Vendor Audit SAP Risk Assessment Vendor Documentation TMS Deviation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Lead the vendor qualification process, including the evaluation and approval of new and existing vendors. Review and approve vendor documentation to ensure compliance with internal standards and regulatory requirements.
Manage QMS notifications, ensuring timely resolution of issues related to change control, deviations, and CAPA. Oversee the preparation, review, and approval of SOPs to ensure alignment with current practices and regulatory standards.
Conduct comprehensive risk assessments and risk analysis to identify potential quality issues and implement mitigation strategies.
Independently plan, conduct, and report on vendor audits, coordinating with internal and external stakeholders to schedule and execute audits.

Preferred candidate profile

Bachelors or Masters degree in Pharmacy from a reputed institution.
Should have 10 -15 years in corporate quality assurance roles within the pharmaceutical, biotechnology, or related industries.
Should be proficient in quality management software such as Trackwise, Caliber, SAP, TMS, DMS, and QAMS.
Should have experience in vendor qualification management, vendor documentation and managing vendor audits.

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