Executive (Internal Compliance)
Singapore Legal
Job description
Job Description
Support, execute and maintain QA compliance work which include the following:
Coordinating and preparing Annual/ Product Quality Review (APQR) and its follow-up actions
Performing Customer Complaint investigation and its follow-up actions
Supporting Self-Inspection program,
Act as Subject Matter Expert (SME) for maintenance of Novartis Quality Manual assessment,
Supporting maintenance of External Standards/ Global Lessons Learnt/ Rapid Alerts assessment and and Global Operating Procedures
Supporting maintenance of inter-site Quality Agreements,
Coordinating and reporting of site Quality Metrics,
Change Control review/ assessment,
Preparing & facilitating Quality Council Review meetings
Supporting the management of health authority/ regulatory inspections and its follow-up actions
Providing QA oversight for validation (equipment requalification) activities to ensure compliance with internal and external regulatory expectation through activities that include but not limited to review and approval of validation protocol and report
Support the implementation and maintenance of quality management systems and promote awareness of regulatory compliance requirements such as GMP, ISO 13485
Support any other regulatory compliance activities as assigned by QA Compliance Lead.
Position Title
Executive (Internal Compliance)
Desired profile
Minimum requirements
Degree in Science or Equivalent Proficiency in English, both written and spoken One to two years of experience in pharmaceutical/ medical device regulations or internship experience in GMP compliance is preferred.
Job Type
Full Time
Country
Singapore
Work Location
Singapore
Functional Area
Quality
Division
ALCON
Business Unit
QUALITY ASSURANCE AL
Employment Type
Regular
Company/Legal Entity
ALCON MANUF. SGP