Posted 4 years ago
Location: McPherson, KS
Start date: 10/01
Category : Full Time
- Perform Chemical assessment to determine the storage conditions of the finished, semi-finished products, work in progress chemical, active pharmaceutical ingredients (API’s), other chemicals and manufacturing components (eg: vials, ampoules) of pharma products.
- Develop and Execute Validation life cycle deliverables which include Validation plans, requirement specifications, Risk Assessments, test plans, (IQ, OQ, PQ) protocols, Traceability Matrix and validation reports for the Liquid Injectable Laboratory and Manufacturing Equipment’s as well as Utilities, HVAC’S and Facility in compliance with GxP and FDA guideline
- Execute Temperature (thermal) Mapping studies, calibrating and operating a Kaye 2000 Validator and Veriteq Data Loggers including instrument calibration using NIST (National institute of Science and Technology) traceable standards for Cold Rooms and -80°C Freezers.
- Qualify and Review HEPA carts, Compounding Tanks for manufacturing controlled drugs, CTU’s (Controlled temperature units) such as freezers, refrigerators, incubators, by following cGMP standards and advanced quality control techniques.
- Accurately perform various clean-room validation tests such as filter integrity testing; particle counts to control airborne contaminants both in clean rooms, clean zones and clean room hoods (laminar and non-laminar flow hoods) within positive and negative pressure differential environments.
- Develop IQ, OQ & PQ protocols with Documentum for managing technical documentation of projects and annual product review.
- Prepare and review the validation compliance reports about existing status of the cGMP, GCP, GLP, GDP, ISO, and OSHA in accordance with ICH guidelines.
- Executes and ensures that all Quality Events (QEs), Notice of Events (NOEs) and CAPA’s are completed/closed within the established time-frame, Identify potential issues / Trend analysis – work with other teams to address the issue, propose solutions using sound scientific techniques to measure effectiveness to prevent re occurrence.
- Involve in data integrity special project assignment performing assessment to validation documentation to guarantee that GMPs data generated complies with the ALCOA, 21 CFR part 11 (electronic records/ Electronic Signatures), part 211 (Injectable drug products) and FDA regulations.
- Perform the analysis to determine the acceptance for effectiveness verification of CAPA, monitor all phases of the CAPA investigations for the timely completion: Initiation, immediate actions, evaluation (including risk assessment), root cause, investigation plans, investigations, implementation, risk re-evaluation and final closure.
- Initiate and ensure that the investigations and CAPA (Corrective Action and Preventive Action) assure the Quality systems are in accordance with ICH, FDA – Good Manufacturing.
- Perform investigations and report results in cleaning, process, equipment, HVAC’s, could include discrepancies involved in the manufacturing of the bulk drugs, work orders, verification of physical and chemical properties of the products.
- Involve in mitigating the quality issues and tracking the deviations, incidents, QAR (Quality assurance reports), event reports, change controls, action items by using the Trackwise and VITS.
- Bachelor’s in Chemistry or Equivalent is required
- 1-5 years relevant experience
- Strong technical writing to develop client SOPs
- Excellent communication skills
- Excellent attention to detail, analytical and problem-solving skills
- Experience in writing IQ, OQ and PQ protocols
- Knowledge of GMPs, GDPs, GLPs