Role DescriptionSupport the value stream organizational structure, take care of all non-routine Quality Control activities for example: o Laboratory Quality Control Product Specialist (Knowledge of specific product characteristics) o Lead of phase II OOS- en complex investigations o Stability trending, o Lab Outsourcing, o Quality Analyst Job Training o Equipment care (maintenance/validation/calibration) o SME during Regulatory and client inspections
• Quality Control testing o Back-up for testing and evaluation of quality of Raw materials, API, Packaging components (primary and printed) Drug Product throughout manufacturing process and during shelf life of the drug product (Stability testing) o Back-up for testing, approve or reject of the raw materials, packaging materials & finished products, stability samples as per the committed time lines.
Responsibilities• Handling failure investigations. o Timely management of (OOS) investigations, CAPAs, Regulatory commitment, GRAs, Audits, to ensure sustainable compliance. o Write study protocol and report as part of failure investigations. o Actively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions.
• Documentation o Assistance in the establishment of standards, specifications, sampling plans, test procedures, or any other laboratory control mechanism. o Assistance in the development and implementation of the quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment and compliance with regulations; prepare and maintain applicable records.
• Stability: o Handling stability studies as per the regulatory requirement. o Timely preparation, review and approval of stability trend & evaluation reports.
• Qualification o Maintain own technical expertise, personal skills and interpersonal skills needed to perform their duties in line with site expectations. o Demonstrate decision-making abilities in all aspects of performance.
Requirements- HBO - Experience with pharmaceutical processes, chemical analysis techniques, and cGXP - Experience on instrument like HPLC, GC, KF. - Familiar with process automation. - Familiar with Lean Lab concept. - Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVISA - Good Knowledge of English (verbal and in writing)
Other informationYou will be working in shifts: 0700-1530 1500-2330 2300-0730
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.