This position is a member of the Quality Systems team which supports the implementation and maintenance of various Quality Systems and to guarantee the quality oversight for validation related activities which includes Data Integrity at site.
Responsibilities
• Support the site projects on Qualification/ Validation
· Assessment and Approval of Documents
• Responsible to review and approve the Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.
• Support collaboration and participations in projects as Quality Representative for Quality Systems and Validation.
• Support in multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between the plants.
• Any other duties as assigned by Manager/ Supervisor.
Requirements
• Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline.
• Certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
• Min experience of 2-3 years in the pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation
Interested candidates please send in your resume to:
EA Personnel: Valerie Yong Kian Fung
CEI No.: R1103704
Recruit Express Pte Ltd, EA License No.: 99C4599
