Job Description

PREFERENCE : EXPERIENCE IN PHARMACEUTICAL INDUSTRY 1-4 YEARS

KEY RESPONSIBILITIES

:

1.1 To conduct Quality Assurance Department job functions.

1.2 To assist Manager in implementing and controlling Pharmaceutical Quality System (PQS) and procedures with respect to Purity, Identity, Quality, Efficacy and Safety of products and materials for the Site.

1.3 To ensure all activities are complying with Standard Operating Procedures, Safety procedures of OSH and Safety Policy.

1.4 To ensure relevant training is given to all staffs from time to time and assessment via evaluation for continual improvement.

1.5 To ensure all activities are complying with Good Manufacturing Practice (GMP) per PIC/S Guidelines, QMS (other standards) and other local regulations.

1.6 To plan and execute any project or tasks assigned.

KEY ACCOUNTABILITIES

COMPLIANCE

To ensure the Site Master File is updated on a regular basis.

To ensure Validation Master Plan is updated on a regular basis.

To drive all compliance activities and certification programs.

To support in auditing (GMP) for company's internal audit and Supplier Audit.

To attend to visit by external auditors, regulatory and enforcement officers

PRODUCT QUALITY

To ensure actions are taken to minimize product complaint as per business plan limit and review CAPA effectiveness.

To ensure CAPA (Corrective Action and Preventive Action) is carried out to meet the Quality Objectives set.

To ensure all materials are not released for use and products are not released for sale until their quality status are acceptable according to the standards used.

QUALITY ASSURANCE RESPONSIBILITIES

To ensure the Internal Audit systems are in place and activities are carried out at least once a year.

To ensure documentation are properly controlled, reviewed and updated regularly.

To ensure all equipment calibration are managed and controlled accordingly.

To ensure equipment and facilities are qualified.

To ensure all manufacturing processes are validated as scheduled in the Site Validation Master Plan.

To review all validation and qualification documents.

To oversee registration matters pertaining to registration of products.

To update and ensure all relevant documentations are up to date.

To support Superior for release/reject of Batch Manufacturing Record for production used and for release of goods for sale.

Job Type: Full-time

Pay: From RM2,000.00 per month

Benefits:

Free parking Health insurance Opportunities for promotion Parental leave Professional development
Education:

Bachelor's (Required)
Work Location: In person