Sr. Officer/Executive - QA

Ipca; Munger; On-site; INR 900,000 - 1,100,000; Full time

Job summary

Ipca is seeking a QA professional with 3 to 8 years of core QA experience in a USFDA-approved API plant to join our quality assurance team. The role focuses on ensuring line clearances, batch release through BPCR review, and robust CAPA implementation through root-cause analysis.

The candidate will participate in protocol reviews for process, cleaning, and equipment validation, and contribute to internal and USFDA audits, SOP maintenance, and staff training to uphold our high regulatory

Qualifications

• 3 to 8 years of core QA experience in a USFDA-approved API plant.

Responsibilities

• Issue line clearances for all API manufacturing and packing stages.
• Review Batch Production & Control Records (BPCR) and analytical data for batch release.
• Investigate deviations, handle change controls, and implement effective CAPAs using root-cause analysis.
• Review protocols for process, cleaning, and equipment validation; participate in internal and USFDA audits.
• Draft, revise, and train staff on Standard Operating Procedures.

Skills

QA experience

Job description

Role & responsibilities

• Shop-Floor Compliance: Issue line clearances for all API manufacturing and packing stages.
• Batch Record Review: Review Batch Production & Control Records (BPCR) and analytical data for batch release.
• QMS Management: Investigate deviations, handle change controls, and implement effective CAPAs using root-cause analysis.
• Validation & Audits: Review protocols for process, cleaning, and equipment validation; participate in internal and USFDA audits.
• SOP Maintenance: Draft, revise, and train staff on Standard Operating Procedures.

Preferred candidate profile

• 3 to 8 years of core QA experience in a USFDA-approved API plant.