Role & responsibilities

- Execute and coordinate Process Validation (PV) activities as per approved protocols.

- Prepare, review, and execute Cleaning Validation protocols and reports.

- Support Equipment Qualification activities including DQ, IQ, OQ, and PQ.

- Support validation of manufacturing processes, utilities, systems, and facilities.

- Ensure validation activities are completed within the approved timelines.

- Prepare and review validation protocols, reports, and related documents.

- Review SOPs, specifications, formats, and other QA documentation related to validation.

- Maintain complete and accurate validation records.

- Ensure proper documentation practices and data integrity in accordance with GMP requirements.

- Ensure compliance with GMP, GDP, SOPs, and regulatory requirements.

- Review and support investigation of deviations, incidents, OOS/OOT,



and other quality events related to validation.

- Support CAPA and Change Control implementation.

- Participate in internal, customer, and regulatory audits.

- Ensure timely closure of audit observations related to validation activities.

Preferred candidate profile

- Good knowledge of Pharmaceutical QA and Validation.

- Knowledge of GMP, GDP, Data Integrity, and regulatory requirements.

- Understanding of Process Validation, Cleaning Validation, and Equipment Qualification.

- Good documentation and report-writing skills.

- Strong analytical and problem-solving skills.

- Positive communication and interpersonal skills.

- Ability to work effectively with cross-functional teams.

📌 Quality Assurance Validation Officer (Vapi)
🏢 BIOALTUS
📍 Vapi