Senior Executive - Clinical QA (Corporate Quality Assurance)

Alembic Pharmaceuticals Limited; Vadodara; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Alembic Pharmaceuticals Limited seeks a QA professional to conduct Investigator site audits and monitoring across Clinical Trial, Patient PK, and BA/BE studies, ensuring compliance and data integrity.

Responsibilities include auditing Investigator/CRO/Vendor qualifications, handling Informed Consent, IMP shipments, source documents, and essential records; applying ICH GCP/GLP; drafting audit reports and CAPA actions.

Qualifications

• Experience with Investigator site audits or monitoring of clinical studies.
• Experience in Investigator/CRO/Vendor qualification audits.
• Regulatory knowledge for USFDA/EMA/Canada/TGA/ANVISA and study protocols.
• Hands-on handling of informed consent, IMP shipments, source records, and essential documents.
• Understanding subject safety, data integrity, protocol compliance, and study documentation.
• Knowledge of Quality Management System; SOPs, deviations, CAPA, change control, training records.
• Experience writing monitoring/audit reports and corrective actions.
• Training on ICH GCP and GLP requirements.

Responsibilities

• Role & responsibilities excerpted from provided HTML block.

Skills

Investigator audits

Regulatory compliance

ICH GCP/GLP

Audit reporting

CAPA & change control

Job description

Role & responsibilities:

• Experience of conducting Investigator site audits or monitoring of Clinical Trial/Patient PK studies or BA/BE studies.
• Experience of conducting Investigator/CRO/Vendor qualification audit.
• Well versed with various regulatory requirements (eg.USFDA/EMA/Canada/TGA/ANVISA etc.) for preparation and review of study protocol and site SOPs.
• Hands-on experience of handling Informed consent documentation/process, IMP shipment records, source records, essential documents, and study-related data.
• Should have thorough understanding of regulatory requirements for ensuring subject safety, data integrity, protocol compliance, and study documentation.
• Sound knowledge of Quality Management System such as SOPs drafting, deviation/ CAPA / change control process, Training Records, Instrument calibration, archive etc.
• Experience of writing monitoring/audit reports and ability to understand corrective and preventive actions taken to any findings.
• Having trained on ICH GCP and GLP requirements.