QA Manager

$ 4,500 / month
Logo of Simpor Pharma Sdn Bhd
Category:
Brunei Jobs
Job Offer:
Administrative / Office Jobs
Salary:
$ 4,500 / month
Region:
Brunei Muara
City:
Bandar Seri Begawan
Local area:
Lot P18, P19, P28, P29, Salambigar Industrial Park, Jalan Utama Tanah Jambu
Job Details:

Position: QA Manager
Total Vacancy: 1 Male

Responsibilities and Duties:

• Direct and lead the Quality Control, Regulatory Affairs, R&D, Engineering, Production and Warehouse as well as Halal Manager.
• Ensure compliance with GMP, PIC/S and Halal regulations as required by Ministry of Health, MORA (Ministry of Religious Affairs) or other jurisdictions in order to obtain GMP and PIC/S status (e. g. the Manufacturing License) and Halal Certification.
• Participate in internal GMP and third party Audits.
• Participate in analytical investigations of out-of-specification (OOS), examine results, change control requests when necessary, generate deviation investigation reports (DIR), root cause determination, and provide recommendation for corrective and preventative actions (CAPA).
• Act as authority for all interaction with Ministry of Health, external agencies and contracts for quality assurance and regulatory compliance related activities and documentation.
• Act as authority on validation of IQ/OQ/PQ, which include test methods, machines, operation process, cleaning, etc.
• Review and approve method transfer and validation protocols and reports.
• Review and approve the product CoAs, Batch Records and Packaging Records to make decisions on release or rejection of products based on sound judgment and compliance to regulatory requirements, reports and specifications.
• Act as authority for customer complaint management and potential recall of all products sold by the company.
• Write, review and revise SOPs, quality policies and procedures, customer methods to ensure continuous compliance with GMP, PIC/S and regulatory compliance as well as customer requirements.
• Provide assistance and technical support for equipment or process optimization, validation, calibration, qualification or certification.
• Complete product regulatory applications and registration for market authorization and the unique requirements of the Foreign Health Authorities, or other jurisdictions.
• Contact customers and internal departments to respond to their inquiries and resolve QA issues.
• Provide assistance for export document application as required by Sales and Marketing team.
• Provide GMP and SOP training for staff.
• Participate in other tasks that may be assigned by the Managing Director.

Qualifications:

• A B. Sc. degree or equivalent in an applicable discipline of science (chemistry, biochemistry, chemical engineering, medicine or related).
• Ten or more years of QC/QA experience in the pharmaceutical/nutraceutical related industry.
• Advanced knowledge of GMP, the US FDA and PIC/S regulations for manufacturing/packaging pharmaceutical or nutraceutical products.
• Familiarity with the regulatory requirements of foreign jurisdictions would be considered an asset.
• Able to work as a team and possess soft skills such as personnel integrity, and interpersonal skills.
• Proven ability to supervise personnel and excellent verbal/written communication skills.

Education Required: Master´´s Degree (Master´´s) or equivalent
Age: 38 - 45 years old
Basic Salary: B$ 4, 500 / Month
Employment Type: Full Time

Closing date: 28/06/2019


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