Qa Executive

United Hr Solutions; Bhopal; Presencial; INR 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

United Hr Solutions is seeking an experienced Quality Assurance Sr. Executive / Assistant Manager Validation in Bhopal to lead pharmaceutical validation activities.

The role requires managing qualification/testing of plant areas and equipment, maintaining compliant documentation, and supporting audits while ensuring regulatory alignment with WHO-GMP, Schedule M, US FDA, and EU GMP. The ideal candidate has 5+ years in pharma validation, strong hands-on IQ/OQ/PQ experience, and solid knowledge of

Formación

• B. Pharm / M. Pharm qualification is mandatory.
• 5+ years of relevant experience in pharmaceutical validation activities.
• Hands-on experience in equipment and area qualification (IQ/OQ/PQ).
• Knowledge of GMP/WHO guidelines and regulatory expectations.

Responsabilidades

• Prepare and review validation protocols, execution reports, and VMPs.
• Manage qualification of plant areas and equipment (autoclaves, vessels, filling/packing).
• Review tech transfer docs, SMF, and other validation records.
• Track calibration/qualification activities to meet regulatory timelines.
• Prepare QRM assessments for areas/equipment.
• Investigate deviations and implement CAPA actions.
• Support audits/inspections and respond to observations.
• Ensure compliance with WHO-GMP, Schedule M, US FDA 21 CFR 210/211, EU GMP.
• Manage validation docs: URS, DQ, IQ, OQ, PQ, PPQ, CPV, CPV records.
• Support CSV, utilities validation, and data integrity.
• Apply ICH Q9 risk-based validation and ALCOA+ principles.

Conocimientos

IQ/OQ/PQ

VMP

CAPA

QRM

FMEA

ALCOA+

Data integrity

Statistical eval

Educación

B. Pharm / M. Pharm

Herramientas

URS, DQ, IQ, OQ, PQ, PPQ

Descripción del empleo

Company Details:

Our client is into pharma manufacturing

Designation:

Quality Assurance Sr. Executive / Assistant Manager Validation

Job Location:

Acharpura Bhopal

Role Overview:

We are looking for an experienced Quality Assurance professional with 5+ years of relevant experience in pharmaceutical validation activities. The candidate will be responsible for managing qualification and validation processes, ensuring GMP compliance, maintaining validation documentation, supporting audits and inspections, and implementing quality risk management practices as per regulatory requirements.

Key Responsibilities:

• Prepare and review validation protocols, execution reports, and Validation Master Plans (VMP).
• Manage qualification of plant areas and equipment, including autoclaves, vessels, filling and packing machines.
• Prepare and review technology transfer documents, Site Master File (SMF), and other validation-related documentation.
• Track calibration and qualification activities to ensure timely completion and regulatory compliance.
• Prepare Quality Risk Management (QRM) assessments for plant areas and equipment.
• Investigate validation deviations and implement appropriate Corrective and Preventive Actions (CAPA).
• Support internal and external audits and regulatory inspections, including preparation of responses and closure of observations.
• Ensure compliance with WHO-GMP, Schedule M, US FDA 21 CFR 210/211, EU GMP, and applicable PIC/S requirements.
• Manage validation documentation, including URS, DQ, IQ, OQ, PQ, PPQ, and continued process verification records.
• Support Computerized System Validation (CSV), utilities validation, and data integrity compliance.
• Apply risk assessment methodologies, including FMEA and ICH Q9, to identify and mitigate quality risks.
• Maintain accurate validation records and ensure compliance with approved SOPs, documentation practices, and ALCOA+ principles.
• Coordinate with Production, Engineering, and other cross-functional teams to ensure effective execution of validation activities.

Key Requirements:

• B. Pharm / M. Pharm qualification is mandatory.
• 5+ years of relevant experience in pharmaceutical validation activities.
• Strong hands-on experience in equipment and area qualification, preferably involving IQ/OQ/PQ.
• Good knowledge of process validation, PPQ, CPV, CPPs, CQAs, and statistical evaluation.
• Experience in validation of utilities, including water systems, HVAC, and compressed air systems.
• Strong understanding of WHO-GMP, Schedule M, US FDA, EU GMP, and applicable regulatory guidelines.
• Proficiency in validation documentation, including VMP, protocols, reports, deviations, change controls, and CAPA.
• Knowledge of Quality Risk Management, ICH Q9, FMEA, and risk-based validation approaches.