Roles and Responsibilities:

- Develop and execute Validation strategies in line with client needs and regulatory guidelines (GxP, 21 CFR Part 11, GAMP 5, ICH Q9).
- Create and maintain validation documentation, including Validation Plans, IQ/OQ/PQ protocols, URS, RTM, and other required documents.
- Conduct impact assessments, risk assessments, and manage change control processes.
- Handle CAPA, incident management, and release management activities related to Validation activities.
- Develop and maintain in-house SOPs related to Validation processes and ensure adherence to QMS.
- Utilize JIRA for tracking tasks, issues, and project progress.
- Collaborate with cross-functional teams to ensure successful Validation Documents preparation.
- Stay up-to-date with industry best practices and regulatory changes related to Validation.

Qualifications:





- 1+years of proven experience in serialization implementation within the pharmaceutical industry.
- Solid understanding of regulatory requirements (GxP, 21 CFR Part 11, GAMP 5, ICH Q9).
- Experience with validation protocols (IQ, OQ, PQ) and documentation (URS, RTM).
- Familiarity with quality management systems (QMS) and SOP development.
- Proficiency in using JIRA or similar project management tools.
- Excellent communication and interpersonal skills.

Preferred Skills:

- Experience with specific serialization software and hardware solutions (mention specific platforms if applicable).
- Knowledge of supply chain management principles.
- Certification in relevant areas (e.g., quality management, project management).

📌 Jr.Computer system Validation (Hyderabad)
🏢 AltiusHub
📍 Hyderabad