Responsibilities : Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standar.....
Responsibilities :
Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements.
Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
Use Imex "ways of working" for day-to-day operations, problem solving, escalation and continuous improvements.
Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed.
Assess impact to products based on compendial monograph changes/updates/introduction.
Support regulatory submissions and queries for post transfer activity.
Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
Conduct Laboratory investigations and propose CAPA for the identified root cause.
Train colleagues in hands on training of instruments and methods written
Perform review and approval of test results.
Able to write position paper, protocols, reports and test procedures.
Ability to handle QTS actions and raise and complete change controls for changes with GMP impact.
Involve in regular meeting with donating site and facilitate the smooth transfer of the methods.
Conduct trainings for fellow QC colleagues on new methods in the laboratory.
Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated.
Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution.
Perform cleaning method development and validation.
Ensure following the site GDP practice on documentation and preparation of document.
Method verification in accordance to site or pharmacopeia standards and according to schedule.
Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities.
Job Skill Requirements:
Min. Degree with 5 years of QC Experience in pharmaceutical or related industries
Demonstrated technical skills in method transfer, validation, verification and testing.
Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures and governmental regulations
Experienced in Method Transfer, Method Validation and Method Verification activity.
Knowledge of cGMPs and ALCOA principles.
Laboratory work experience with analytical HPLC, GC, FTIR, UV, KF and other lab equipment.
Experienced in leading continuous improvement projects
Knowledge of lean manufacturing, six sigma methodologies, and statistics
