Quality Assurance - Dy.Manager /Manager

Biological E

11 - 15 years

6 - 11 Lacs

hyderabad telangana india

Posted:1 day ago| Platform: Foundit logo

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Skills Required

sop review validation risk assessment audit support qms qualification

Work Mode

On-site

Job Type

Full Time

Job Description

Validation Master Plan (VMP):
Lead the preparation, review, and maintenance of the Validation Master Plan (VMP) to ensure alignment with industry standards and regulatory requirements.
Qualification/Validation Protocols:
Review and approve Qualification/Validation protocols to ensure they comply with CGMP standards and regulatory requirements.
Quality Systems Maintenance:
Ensure all quality systems are maintained according to CGMP requirements and monitor compliance across all departments.
SOP Review & Approval:
Review and approve Quality Assurance (QA) SOPs as well as SOPs from cross-functional departments to ensure consistency and regulatory compliance.
Document Review & Compliance:
Review and approve critical documents, including URS (User Requirement Specifications), Impact Assessments, FAT (Factory Acceptance Tests), DQ (Design Qualification), FDS (Functional Design Specifications), and HDS (High-Level Design Specifications).
Execution Oversight:
Ensure compliance with GDP (Good Documentation Practices) and CGMP procedures during the execution of validation and qualification activities.
Quality Management System (QMS):
Initiate and review key QMS elements such as Change Controls, Deviations, and CAPA (Corrective and Preventive Actions) to ensure timely resolution of quality issues.
Validation Documentation:
Review and approve all validation documents and reports, ensuring their compliance with internal standards and regulatory requirements.
Qualification/Calibration Planning:
Oversee the review and approval of Qualification/Calibration schedules and annual plans to ensure timely execution of required activities.
Risk Assessment Participation:
Participate in Quality Risk Assessment exercises in collaboration with cross-functional teams to identify and mitigate risks.
Audit & Compliance Support:
Lead and support during regulatory audits, customer visits, and inspections to ensure facility compliance with relevant standards.
Verify facility readiness for customer and regulatory audits, providing necessary documentation and supporting compliance activities.

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