Quality Assurance - Deputy Manager/Manager
Biological E Ltd. · Hyderabad · onsite · Posted 55d ago
Not disclosed11–15 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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.
Sourced from foundit
Skills
validationQualificationAudit SupportRisk AssessmentQMSSOP Review
About Biological E
Biological E Ltd.
Pharma
3.4k+
employees
1953
73 years old
Hyderabad/Secunderabad, Telangana
India
₹6.4L PA avg
Avg at Biological E
About
Leading Indian biopharma firm supplying vaccines to 130+ countries, known for producing over 2 billion COVID-19 doses and advancing global immunization efforts.
Industries
Pharma
Employee ratings
10 reviews
4.2/ 5
Culture
3.7
Career growth
3.6
Work-life
3.6
Employees rate it well for
Job Security44Overall Company42
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