Deskripsi Pekerjaan
Join Am-Europharma Corporation as a Technical Services Specialist (Chemical Engineer) and drive excellence in manufacturing compliance through expert technical support. This pivotal role ensures our pharmaceutical operations meet the highest industry standards by overseeing critical validation processes, equipment qualifications, and thorough investigations. You'll be instrumental in maintaining robust documentation systems that align with GMP and FDA regulations while troubleshooting complex technical challenges. Our ideal candidate thrives in dynamic environments where precision, analytical thinking, and collaborative problem-solving converge to enhance product quality and operational efficiency. Am-Europharma offers a culture of innovation and professional growth, where your contributions directly impact our mission to deliver safe, effective pharmaceutical solutions to communities nationwide.
Tanggung Jawab
- Lead process validation and equipment qualification activities to ensure compliance with regulatory standards
- Conduct root cause analysis for manufacturing deviations and implement corrective/preventive actions
- Develop and maintain comprehensive documentation including validation protocols, reports, and SOPs
- Provide technical consultation to production teams on process optimization and equipment performance
- Coordinate cross-functional quality audits and regulatory inspections
- Support continuous improvement initiatives through data-driven technical assessments
- Train staff on validation procedures and compliance requirements
Kualifikasi
- Bachelor's degree in Chemical Engineering or related technical field
- Minimum 3 years' experience in pharmaceutical manufacturing or regulated industry
- Strong knowledge of GMP, FDA, and ISO quality standards
- Proficiency in validation protocols (IQ/OQ/PQ) and equipment qualification
- Experience with root cause analysis methodologies (e.g., 5 Whys, Fishbone)
- Advanced technical writing skills for documentation and regulatory submissions
- Ability to interpret complex technical specifications and engineering drawings
- Strong analytical and problem-solving abilities with attention to detail