Job Summary
Develop, apply, and maintain quality standards for sample testing processes and comply with regulations. Schedule meetings with management to update them on projects and equipment.
Essential Responsibilities
Implement management activities within SOPs for the lab and R&D/Validation tests.
Work in cross-functional teams to achieve departmental goals.
Ensure lab personnel follow good documentation and lab practices.
Provide technical expertise for customer inquiries.
Maintain impartiality and communicate potential risks to management and Quality Assurance.
Assist in writing and revising SOPs and associated documents.
Contribute to training modules and ensure effective training.
Manage the Department PT program and stay updated on regulatory procedures.
Oversee R&D, Validation, and optimization of lab testing services.
Ensure adherence to method validation and transfer processes.
Manage the dashboard for testing services and interact with management for resources.
Participate in audits and recommend responses to complaints.
Operate and maintain lab equipment, including preventive maintenance.
Maintain technical competence by attending conferences and seminars.
Ensure safe work practices in the lab with the Safety Officer/Committee.
Minimum Qualifications
Baccalaureate Degree in Biological or Chemical Science required; Master's preferred.
Ten years of experience in the cosmetic, pharmaceutical, or related field, and four years in regulatory, quality control, or quality assurance preferred.
Proficiency in 21 CFR, USP/NF, EP, JP, AOAC, ICH, GxP, cGMP, cGLP, and/or ISO standards.
Excellent communication skills in English.
Strong problem-solving abilities.
Proficiency in using Windows programs and various lab software.
Ability to lift and move heavy lab items.
Ability to work efficiently under pressure in a fast-paced environment.
