QA MANAGER [ MANUFACTURER /MEDICAL /ISKANDAR PUTERI ]
Specialisation: Manufacturing/Production Operations
Education Qualification: Bachelor Degree
Post Graduate Diploma
Post Graduate Diploma
Work Location : Iskandar Puteri, Johor
Salary Range : RM 10,000.00 – 12,000.00
Posted Date : August 09, 2019
- Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Biology, Chemistry, BioTechnology or equivalent.
- At least 5 year(s) of working experience in the related field is required for this position.
- Preferably Managers specializing in Quality Control/Assurance or equivalent.
- Full-Time position(s) available.
- Preparing and review of Quality Assurance Standard Operating Procedures
- Review of others related department procedures specifically for Production Drug Products, Product Drug Substance, warehouse drug products, warehouse drug Substance, Enviroment safety and Health, instrumentation and Automation and Engineering and Maintenance
- Authorised to arrpove related procedure, protocol and report specifically for Production Drug Product, Product Drug Substance, warehouse drug products, warehouse Drug Substance, enviroment safety and health, Instrumentation and Automation and Engineering and maintenance
- Coordinate meeting between cross functional teams
- Participate in peer review for Quality Assurance , Production Drug Products, Product Dug Substance , warehosue Drug Products, warehouse Drug Substance, Warehouse drug Products, warehouse Drug Substance, enviroment safety and Health , Instumentaion and Automation and Engineering and Maintenance and related procedure.
- Initiation of change management and reviewed of required Change management especially pertaining of Production Drug products , Production Drug Substance as part of the change management Panel.
- Initiation of QA related deviations including investigation, root cause identification and determination of CAPA.
- Audit-Internal and external (partners, Customers, Regulatory) and support in Audit Compliance.
- Performing the CGMP audits inclusing the preparation of reports and follow up the CAPA
- Review and Support of cleaning validation and process validation documents and activities for Production Drug Substance and Production Drug Product.
- Routine review and updation of PVMP, CVMP and CSVMP as per defined criteria
- Training of the QA personnel
- Document handling for the process Validation, Cleaning Validation, supplier qualification,equipment qualification,transport validation ,computer system validation and study protocols and reports for both Drug Product and drug Substance
Kindly contact the following consulltant at 07-2305453 for further details or send your resume to Talent Resource Unit [ firstname.lastname@example.org ] / Mohd Haron [ email@example.com ]