Quality Assurance Validation Officer

BIOALTUS; Vapi; On-site; INR 600,000 - 1,200,000; Full time

Job summary

BIOALTUS in India is seeking a QA and Validation professional to execute and coordinate Process Validation activities per approved protocols. You will prepare, review, and execute Cleaning Validation protocols and reports, and support Equipment Qualification (DQ/IQ/OQ/PQ).

The role involves validating manufacturing processes, utilities, systems and facilities, maintaining records in compliance with GMP, GDP and data integrity standards, and ensuring timely closure of audit observations related

Qualifications

• Experience in pharmaceutical QA and validation processes.
• Familiarity with GMP, GDP, data integrity and regulatory requirements.
• Ability to write clear validation reports and SOPs.

Responsibilities

• Execute and coordinate PV activities per approved protocols.
• Prepare, review, and execute Cleaning Validation protocols and reports.
• Support Equipment Qualification (DQ/IQ/OQ/PQ).
• Validate manufacturing processes, utilities, systems, and facilities.
• Maintain complete validation records with proper documentation.
• Ensure compliance with GMP, GDP, SOPs and regulatory requirements.
• Support investigations of deviations, OOS/OOT and other quality events.
• Assist CAPA and Change Control implementation.
• Participate in audits and ensure timely closure of observations.
• Ensure validation activities meet approved timelines.

Skills

GMP & GDP knowledge

Process Validation

Cleaning Validation

Documentation skills

Job description

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.
• Good communication and interpersonal skills.
• Ability to work effectively with cross-functional teams.