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Quality Assurance Specialist
2 months ago
Job Summary
Leadership responsibility to manage quality assurance and compliance programs and business excellence efforts at TCG GreenChem. Represent as in house worldwide expert in cGMP regulations and understanding phase appropriate development requirements in drug substance development process. Assist in overseeing practices assuring implementation and achievement of company strategic objectives with respect to the quality system. Take company responsibility and represent TCG GreenChem for all clients’ QA and regulatory requirements. Develop and implement quality management systems, which enable operational excellence.
Principal Duties
- Overall responsibility in establishment and improvement of the cGMP compliance in TCG GreenChem
- Interpret company guidelines and guidance of FDA, EMEA and relevant regulatory agencies for the company
- Establish and update cGMP standard and guidance to API development process including material handling and documentation requirement and understanding NCE development processes and commercialization process
- Advocate for improvement, simplification of cGMP compliance and harmonization with TCG GreenChem and industrial practices.
- Support in establishment, management, and enforcement of company SOPs
- Support to establish and implement company training programs regarding cGMP
- Clear understanding of the validation activities to qualify facility and equipment for GMP application
- Identify and educate appropriate key managers for maintaining the information system
- Timely, proactively and creatively address audit /inspection findings, feedbacks and suggestions to streamline, simplify and enhance compliance programs
- Implement appropriate compliance practice and concept with the basis of risk analysis and business ramification
Job Qualifications
- PhD or MS in analytical or organic chemistry and 7+ years relevant experience preferably in analytical chemistry, API development and scale up/manufacturing, or at least 7+ years leadership position to enforce cGMP compliance and regulatory affairs
- Thorough knowledge of FDA, ICH, EMEA, OSHA, EPA, DEP, and guidance of relevant agencies
- Demonstrated a track record of success to interpret and apply cGMP regulatory requirements for API or formulation development process
- Demonstrated track record of success in establishment and streamline of cGMP training programs
- Track record of success in recruiting, mentoring and leading teams of multiple functions, to achieve compliance objectives
- Must be able to swiftly make critical decision and write investigational report, protocol, memo and drafts of compliance matters
- Exceptional communication skill in writing and verbal, able to negotiate and persuade. Demonstrated skill and ability to work on international team and committees
Skills Required
- Excellent verbal and written communication
- Proficient in Microsoft Office
- Critical thinking
- Problem solving
- Active listening
- Out-of-the-box thinking
- Team player is a must
- Proactivity
- Knowledge of technology trends
- Knowledge of regulatory requirements
- Energetic
- Ability to multitask
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