Site Quality Assurance / Quality Control Managers

$ 3,000 / month
Logo of Simpor Pharma Sdn Bhd
Category:
Brunei Jobs
Job Offer:
Manufacturing Jobs
Salary:
$ 3,000 / 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: Site Quality Assurance / Quality Control Managers
Total Vacancy: 1 Male/Female

Responsibilities and Duties:

Ø To direct and lead the QC team to perform routine chemical, physical and microbiological testing of pharmaceutical and nutraceutical materials/ingredients, formulations and finished products.
Ø To review and approve QC tests for raw materials, packaging materials, bulk products and finished products.
Ø To release and reject batches of raw materials and packaging materials.
Ø To review and approve stability summary reports, calibration reports and analytical monographs.
Ø To approve sampling instructions, specifications, test methods and other quality procedure.
Ø To 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).
Ø To ensure corporate compliance with GLP, GMP and PIC/S regulations as required by Ministry of Health or other jurisdiction with a focus in maintaining GLP, GMP and PIC/S Manufacturing License (or other legal licenses).
Ø To ensure the appropriate validations, including those of analytical procedures and methods.
Ø To provide assistance and technical support for equipment or process optimization, validation, calibration, qualification or certification.
Ø Responsible for the maintenance of laboratory equipments and premise.
Ø As the 2nd designated person to release and reject batches of bulk products and finished products.
Ø As the 2nd designated person for customer complaints.
Ø As required, provide assistance with internal GMP and third party Audits.
Ø As required, develop and update policies and SOPs related to GLP, GMP and PIC/S regulations.
Ø To provide GLP, GMP, SOP and laboratory safety training to Quality Control personnel.
Ø Demonstrate time management and project organizational skills.
Ø To participate in other tasks that may be assigned by the Managing Director.

Qualifications:

Ø B. Sc. degree in an applicable discipline of science (chemistry, biochemistry, biology or related) or specific medical training (pharmacology, pharmacokinetics, nutritional research or related).
Ø Five or more years of QC experience in the pharmaceutical, nutraceutical or related industry.
Ø Advanced knowledge of GMP, US FDA and PIC/S regulations for manufacturing pharmaceutical or nutraceutical products.
Ø Familiarity with laboratory equipment (e. g. HPLC, GC, and ICP).
Ø Proven ability to supervise personnel and excellent verbal/written communication skills.

Age: 35 - 50 years old
Basic Salary: B$ 3, 000 / Month
Employment Type: Full Time

Closing date: 31/05/2019


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