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Quality Assurance - Dy.Manager /Manager

Biological E
11-15 Years
Hyderabad
Quick Apply
  • Posted 4 days ago
  • Over 50 applicants have applied

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.

About Company

Biological E. Limited (BE), the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. Originally incorporated as Biological Products Private Limited, and launched by Dr. Vijay Kumar Datla, today, BE is a globally recognised vaccine manufacturer and has supplied over 2 Billion Doses of Vaccines till date all over the world. BE supplies several essential and lifesaving Vaccines and Pharmaceuticals to UN Agencies viz. UNICEF, PAHO, many global markets, and in India to the National Immunization Program, various State Governments, PSUs, Indian Armed Forces and the domestic retail market.

Over the last many decades, Biological E. Limited expanded its product portfolio to cover a whole range of pharmaceutical formulations targeting different therapeutic segments including Respiratory, Cough Management, Gastrointestinal, Nutraceuticals, Anti-Infective, Analgesics and Critical Care. In this journey Biological E has created many legacy brands that offer high-quality trusted solutions to the doctors to handle the most common health challenges the country faces. The wide reach of our sales and distribution team also ensures that these brands are available all across the country, be it the top metros or the remotest of the villages.

We use science based innovation for developing products to meet the specific needs of the end consumers. We focus on developing affordable, efficient and high quality products for acute therapies.

Job ID: 114072217

Last Updated: 28-08-2026 11:55:21 AM
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