Executive (Internal Compliance)

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