Junior QA Pharmacist
|Client||Pharma Dynamics (Pty) Ltd|
|Location||Cape Town, Western Cape, South Africa|
Are you a pharmacist with one year plus experience in quality control /quality assurance or seeking an opportunity in quality assurance within a corporate environment?
|Job Functions||Quality Control|
|Industries||Pharmaceutical / Medical / Healthcare / Hygiene|
•Manage and coordinate the release to market process
•Conduct Batch release reviews and approve final product release to the market as per the legal requirements and guidelines set by the MCC and Department of Health.
•Ensure that the Pharma Dynamics’ marketed products comply with the medicine registration. Liaise and communicate any non – compliances and discrepancies with the Regulatory department. Ensure that the change control process is initiated for any variations and tracked until close out. Any deviations must be recorded sufficiently before any release to the market is authorized.
•Ensure the timeous testing for post importation requirements and documentation thereof with contract laboratories
•Review all batch documentation relating to the lot release of all products - manufacturing, packaging and analytical records - in compliance with registered dossiers
•Review and approve Bulk Material inspections before packaging and liaise with contractors, maintain registers
•Review and approve final packed product inspection, maintains the product trend charts Ensure that the lot release register for all products are updated on an ongoing basis
•Investigate on-line issues and deviations at contractors to avoid an impact to quality and regulatory compliance of company products. Responsible for documented reporting in this regard.
•Conduct, review and approve root cause investigations.
Good Manufacturing practice (GMP, GLP, GWP)
•Support QA Manager in maintaining and coordinating all GMP principles (Quality management, Personnel and training, Premises and requirements, Documentation, Production, Quality Control ( QC), Contract manufacture (including printed material and packaging material), Complaints and Recall, Self- inspection, Quality Risk Management and Audits)
•Co-ordinate or manage specific aspects of GMP as directed by QA Manager
•Compile monthly progress reports on all the principles within the GMP portfolio and on request from management
•Review implementation of change controls and authorize close-out
•Ensure implementation of any corrective or preventative action which has been identified by suppliers, customers, reports by QA Co-ordinators etc
•Review, approve and monitor out-of-specs; complete a root cause analysis and conduct risk assessments
•Review reports of QA Coordinators relating to temperature monitoring results post importation and provide final approval.
•Preparation , compiling and maintenance and review of new business development projects (new products)
•Compile standard and non-standard reports relating to deviations, risk assessments, stability reports etc
•Attend to QA correspondence and communication
•Maintain the contractor master documentation repository at Pharma Dynamics ensuring that the company is in regulatory compliance with its current MCC licensing conditions for manufacture, packing and testing
This pertains to master copies of product batch manufacturing documents (BMR), batch packing documents (BPR), analytical methods, product specifications, stability protocols and validation protocols.
•Maintain the internal QA documentation repository at Pharma Dynamics ensuring that the company is in regulatory compliance with its current MCC licensing conditions for manufacture, packing and testing ( templates, forms, charts registers and reports)
Update the company Electronic Document Management System with all relevant information
•Any other projects as required by QA Manager
•B. Pharm registered with the SA Pharmacy Council
•Minimum of 1 to 2 years work experience in a quality control /quality assurance position. Alternatively, in Retail Pharmacy and seek an opportunity in quality assurance
TECHNICAL COMPETENCIES REQUIRED
•Detailed knowledge relating to all aspects of quality control
•Sound knowledge of the most recent analytical laboratory techniques, packaging analysis, in-process requirements and production controls
•Knowledge of pharmaceutical, generics or consumer healthcare industries
•Knowledge of production and packaging technology
•High computer literacy and able to effectively use Excel
•Up to date knowledge of validation, GMP and GLP
|Job Closing Date||03/02/2017|