Senior Scientist (Training Coordinator)

Key roles and responsibilities

• Development and maintenance of job codes specific for Testing, Micro and QC Ops team for basic and role specific tasks.

• Compliance Management: Use the Master Control system to assign training to QC personnel.

• Maintain the CV for all QC personnel

• Onboarding (NEO): Lead the technical integration of new hires, moving them from general orientation to bench-ready status.

• SOP Oversight: Collaborate with subject matter experts (SMEs) to update SOPs and assign training to personnel who need to be trained

• Audit Support: Serve as the primary point of contact for training records during internal and external (FDA, EMA) audits.

• Filing and Archival of training documents for QC personnel

• Any other roles assigned by the line manager

Job Requirements:

• Bachelor's degree in Chemistry, Biology, Pharmacy, or a related scientific field.

• 3-5 years in a GMP laboratory environment prior experience in training or lead roles preferred.

• Deep understanding of FDA, EMA, ICH related regulations

• Good command of both written and spoken English.

Other Special Requirements:

• A good understanding of the overall view of drug development process.

• A thorough understanding of the principles and management of cGMP compliance, and strong quality minds

• Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.

• Comprehensive knowledge in IND/IMPD, NDA and ANDA filing

• Able to explain ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) to new hires.

• Full time on-site work requirements