In-Process Quality Specialist (IPC) – New Capital Manufacturing

About the role

The In-Process Quality Specialist (IPC) ensures that all in‑process quality controls are performed and monitored during manufacturing operations at the New Capital site. This role supports product quality, regulatory compliance, and batch release readiness in a GMP‑regulated environment.

Key responsibilities

• Perform in‑process checks, sampling, and testing according to approved procedures and regulatory guidelines.
• Handle, clean, and segregate sampling equipment to prevent cross‑contamination.
• Conduct regular GEMBA and shop‑floor walkthroughs to verify compliance with GMP, GEPD, and IPC requirements.
• Review IPC records, batch data, critical parameters, and equipment logs for accuracy and compliance.
• Support the Contamination Control Strategy by identifying gaps, reporting risks, and following defined controls.
• Ensure timely IPC documentation and assist with batch record completion for release readiness.
• Monitor IPC results, flag deviations or trends, and escalate investigations as needed.
• Improve IPC procedures and cross‑contamination controls, including cleaning, validation, and equipment use.
• Coordinate with production to maintain IPC frequencies and ensure required materials and equipment are available.

Required profile

• Bachelor's degree in health‑related sciences, preferably pharmacy.
• Knowledge of cGMP, aseptic processing, and in‑process quality control.
• 2‑3 years of experience in a similar GMP pharmaceutical manufacturing role with aseptic operations.
• Proficiency with computers, MS Office, eQMS, and ERP systems.
• Strong organizational, problem‑solving, and communication skills.
• Ability to work in a highly regulated, labor‑intensive environment and enforce SOPs.

Required skills

• cGMP knowledge
• Aseptic processing
• In‑process quality control
• MS Office
• eQMS
• ERP systems