The In-Process Quality Specialist is responsible for executing and monitoring all in-process quality
controls during manufacturing operations to ensure product quality, compliance with cGMP
activities which directly or indirectly impact the quality of the product manufactured in GEPD New
Capital Manufacturing site.
Key responsibility
- Perform in-process checks, sampling, and testing in accordance with approved procedures and
regulatory guidelines.
- Ensure proper use, handling, cleaning, and segregation of sampling equipment to prevent
cross-contamination.
- Conduct regular GEMBA and shop-floor walkthroughs to verify compliance with GMP,
GEPD, and IPC requirements.
- Review and verify IPC records, batch data, critical parameters, and equipment logs for
accuracy and compliance.
- Support the implementation and maintenance of the Contamination Control Strategy (CCS)
by following defined controls, identifying gaps, and reporting risks related to contamination
prevention.
- Ensure timely and accurate IPC documentation and support batch record completion to enable
batch release readiness.
- Monitor IPC results, identify deviations, atypical events, or trends, and escalate further
investigation.
- Support implementation and improvement of IPC procedures and cross-contamination control
practices (cleaning, validation, and use of dedicated or disposable equipment).
- Coordinate with production to ensure adherence to IPC frequencies and availability of required
materials and equipment.
Academic Experience Required
- Bachelor's degree in health-related Sciences, preferably as a pharmacist.
- Knowledge of cGMP requirements, aseptic processing and in-process Quality Control.
- Professional experience required
- Minimum 2-3 years of experience in similar position at GMP pharmaceutical manufacturing, with aseptic operations.
Computing Skills
- Proficiency in computer, MS Office knowledge.
- Experience with eQMS and ERP systems.
Personal Skills
- Organized and able to manage time effectively.
- Ability to work within a highly regulated, labor-intensive environment.
- Ability to understand, explain, follow, and enforce SOPs.
- Organizational and problem-solving skills.
- Strong integrity and commitment to Quality and Compliance.
- Ability to work in groups and with other departments.
- Excellent oral and written communication skills to produce clear and concise factual findings.
