Kerja Sepenuh Masa ASSISTANT MANAGER- MANAGER - QUALITY ASSURANCE, Gaji tinggi MYR 8,000 di BIOCARE MANUFACTURING SDN BHD Perak - Maukerja

PREFERENCE : EXPERIENCE IN PHARMACEUTICAL INDUSTRY 3-5 YEARS

KEY RESPONSIBILITIES :

1.1 To manage and lead Quality Management Department

1.2 To assist t e General Manager in implementing and controlling Quality Management System (QMS) and procedures with respect to Purity, Identity, 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 OSHA 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.

1.0 KEY ACCOUNTABILITIES

COMPLIANCE

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

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

1.1.3 To drive all compliance activities and certification programs.

1.1.4 As lead auditor/auditor (GMP) for company’s internal audit and Supplier Audit.

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

PRODUCT QUALITY

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

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

1.1.3 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

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

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

1.2.3 To ensure all equipment calibration are managed and controlled accordingly.

1.2.4 To ensure equipment and facilities are qualified.

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

1.2.6 To review and approve all validation and qualification documents.

1.2.7 To oversee registration matters pertaining to registration of products.

1.2.8 To approve relevant documentations.

1.2.9 To act as an authorized person for release/reject of Batch Manufacturing Record for production used and for release of goods for sale.

Job Type: Full-time

Pay: RM4,000.00 - RM8,000.00 per month

Benefits:

• Free parking
• Health insurance
• Parental leave
• Professional development

Work Location: In person