This position is responsible for is overseeing all aspects of the chemistry laboratory operations, ensuring compliance with quality standards, regulatory requirements, and company policies while managing a team of laboratory analysts and engineers.

Role and Responsibilities

● Develop and implement QC strategies to ensure that QC chemical group comply with international regulatory requirements, including but not limited to FDA, EMA, NMPA, WHO, etc.
● Work with department leader to assist teams to improve operation process and activities related to quality.
● Manage data integrity in QC chemical laboratory, ensuring compliance with ALCOA+ principles.
● Draft, revise, and review analytical method transfer/validation protocols and reports; supervise the implementation of corresponding method transfer/validation activities.
● Participate/Guide Chemical lab staff to complete related inspection of API, intermediates and finished products, stability samples according to relevant product specification and SOP.
● Review test records, data and reports, to ensure the accuracy and integrity of data.
● Responsible for lab quality events such as AD/OOS/OOT/Deviation handling & investigation and annual review.
● Responsible for the gap analysis of pharmacopoeia and regulations, and lead the team to mitigate it.
● Lead continuous improvement initiatives for QC Chemical laboratory and promote sharing and implementation of best practices.
● Collaborate with other functional departments (such as QA, CMC, Production, etc.) to coordinate and resolve cross-departmental issues.
● Ensure QC laboratory safely operation, no critical incidents and personal injury.
● Other duties as assigned by line manager.

Qualifications and Education Requirements

● Bachelor and/or advanced degree with major in Pharmacy or related.
● Minimum 8 years of experience working in QC functions in pharmaceutical company. At least 2 years in management position in QC function.
● Should have the ability to make correct judgments and handle problems that arise in quality management.
● Have pretty good knowledge in GMP requirement of QC.
● Familiar with the Chromatogram and Electronic Data of HPLC, GC, IR, UV, PSD etc., LIMS is preferred.
● Familiar with the Pharmacopeia and Guidelines, such as ChP, USP, EP and ICH etc.

Preferred Skills

● Be able to work independently, willing to take responsibility.
● Good personality, hardworking, strong quality mind.
● Good communication skill in both Mandarin and English.
● Good project management skills, able to manage multiple projects simultaneously.