Assistant Manager IPQA

Acme Formulation; Solan; On-site; INR 600,000 - 900,000; Full time

Job summary

Acme Formulation in Solan, Himachal Pradesh, India seeks an IPQA specialist to lead in-process checks, line clearance and GMP/QMS compliance on the shop floor.

The role requires coordinating with Production, QC, QA and Engineering, handling deviations and CAPA, and supporting internal and regulatory audits including USFDA inspections.

Qualifications

• Experience performing IPQA activities for OSD manufacturing and packing.
• Conduct in-process checks and line clearance per SOPs/BMR/BPR.
• Review GMP documents such as BMR/BPR, logbooks, and checklists.
• Monitor processes for compliance with cGMP, SOPs and regulatory requirements.
• Handle deviations, OOS/OOT, CAPA and change control in production.
• Ensure data integrity and proper documentation practices on the shop floor.
• Coordinate with Production, QC, QA and Engineering to resolve quality issues.
• Support internal, customer and regulatory audits, including USFDA inspections.
• Ensure implementation of GMP and QMS on the shop floor.
• Review and approve cleaning, environmental and process records.

Responsibilities

• Handle IPQA activities for OSD manufacturing and packing operations.
• Perform in-process checks and line clearance as per approved SOPs/BMR/BPR.
• Review GMP documents and logbooks to ensure accuracy and compliance.
• Coordinate with Production, QC, QA and Engineering for timely resolution of quality issues.
• Support audits, including USFDA inspections, and ensure GMP/QMS compliance.

Skills

IPQA activities

in-process checks

line clearance

data integrity

GMP compliance

QMS compliance

audit coordination

cross-functional coordination

Job description

Role & responsibilities

• Handle IPQA activities for OSD manufacturing and packing operations.
• Perform in-process checks and line clearance as per approved SOPs/BMR/BPR.
• Review BMR/BPR, logbooks, checklists and other GMP documents.
• Monitor manufacturing processes and ensure compliance with cGMP, SOPs and regulatory requirements.
• Handle deviations, OOS/OOT, CAPA and change control related to production activities.
• Ensure compliance with data integrity and documentation practices.
• Coordinate with Production, QC, QA and Engineering departments for timely resolution of quality issues.
• Support internal, customer and regulatory audits, including USFDA inspections.
• Ensure proper implementation of GMP and QMS requirements on the shop floor.
• Review and approve cleaning, environmental and process-related records as applicable.

Preferred candidate profile

Candidates from OSD formulation plants with exposure to USFDA-approved facilities / regulatory audits preferred.