Sr. Executive Jobs in Documentation – Apply Today at Azurity Pharma
Azurity Pharmaceuticals is inviting applications for the role of Sr. Executive, Documentation Management at its Hyderabad facility. This opportunity is ideal for Life Sciences or Pharmacy graduates with 1–3 years of experience in quality documentation, electronic quality systems, and compliance frameworks such as GxP, 21 CFR Part 11, and EU Annex 11. Be a part of a patient-centric pharmaceutical organization that combines innovation, regulatory excellence, and a commitment to quality.
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a leading specialty pharma company committed to providing accessible and high-quality medications to meet the needs of patients across therapeutic areas like neurology, cardiology, endocrinology, and rare diseases. With a strong commercial product portfolio and late-stage pipeline, Azurity focuses on innovation, compliance, and patient-centric development. The company fosters an inclusive workplace culture driven by integrity and collaboration.
Job Details
Job Title: Sr. Executive, Documentation Management
Location: Hyderabad
Job Description
Brief team/department description:
Associate Documentation Management plays a key role in maintaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position supports integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, ensuring adherence to GxP
and regulatory requirements such as 21 CFR Part 11 and EU Annex 11.Principle Responsibilities
- Maintain and support a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal procedures.
- Support the validation, integrity, and ongoing compliance of electronic quality systems, including document management platforms.
- Support the Documentation Management System, ensuring all controlled documents (e.g., SOPs, policies, work instructions) are accurately authored, reviewed, approved, and updated per lifecycle requirements.
- Oversee document lifecycle activities, ensuring all documentation meets GxP and regulatory standards.
- Support the development, maintenance, and delivery of a GxP training program to ensure relevant personnel remain current with quality and compliance standards.
- Participate in continuous improvement initiatives aimed at enhancing the effectiveness of quality systems and documentation processes.
- Assist in the management and execution of the Computer System Validation (CSV) program, ensuring alignment with 21 CFR Part 11, EU Annex 11, and applicable internal validation policies.
- Support internal and external audits and regulatory inspections by ensuring documentation and systems are readily accessible and compliant.
Qualifications and Education Requirements
- Bachelor’s degree in Pharmacy, Quality, or a related field.
- 1–3 years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry.
- Understanding of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulations.
- Familiarity with electronic Document Management Systems and Computer System Validation practices.
- Strong attention to detail and organizational skills.
Keywords: Azurity Pharmaceuticals, Documentation Management, Pharmaceutical Industry, Quality Management System, Regulatory Compliance
