QA and Responsible Pharmacist - Centurion Verfied

R 450k - 900k per annum Centurion, Gauteng Centurion, Gauteng more than 14 days ago 17-10-2018 11:48:57 AM
12-12-2018 11:48:57 AM
VACANCY: QA and Responsible Pharmacist
DIVISION: Ascendis Animal Health
REPORTING MANAGER: MD Ascendis Animal Health
JOB OBJECTIVE:
• Application of licensing for establishment of an act 101 pharmaceutical company.
• To implement a quality management system, ensure compliance to this system and train and educate stakeholders on the quality
management system.
Documentation forming part of the quality management system would include but is not limited to:
Standard operating procedures
Change control
Master documentation
Deviation
Validation protocols
• Technical customer queries and product complaints.
• Deviation recording and review.
• Vendor approval and supplier audits including all technical quality agreements.
• Batch release.
• Art work and promotional review and approval
• Self-inspection audits
• Change control recording and review.
• Annual product review.
• Ensuring compliance with current GMP.

KEY RESULT AREAS:
• Successfully obtaining all relevant licensing.
• Ensuring that cGMP is maintained for all processes and products.
• Compiling, managing, circulating, updating and logging of SOPs across the brands.
• Raw material and imported bulk COA checking and approval.
• Review and approval of raw materials and raw material primary suppliers and specifying quality requirements of raw materials with suppliers.
• Final Product Release Report (FPRR) and approval per product batch.
• Establish and calculate specifications (raw materials, bulk, stability and final products).
• Management of product stability testing, writing of stability protocols, statistical analyses and reporting of data (as per GMP requirement).
• Reject Report compilation for Quality-related matters, signing, distribution and follow-up.
• Logging, compilation of reports, signing-off on reports, managing and follow-up of Complaints from Contract Manufacturers, Contract
Packers, Wholesalers, Ascendis Animal Health Brands, Customers and Consumers (trending analysis is required as per GMP).
• Pharmacovigilance.
• Non-Conformances and Deviances: Logging, compilation of reports, sign off, managing and follow-up from Contract Manufacturers, Contract
Packers, Wholesalers and Ascendis Animal Health Brands (trending analysis is required as per GMP).
• Out-of-Specifications: Logging, compilation of reports, sign off, managing and follow-up from Contract Manufacturers and Contract Packers
(trending analysis is required as per GMP).
• Conduct Annual Product Reviews (Product Quality Reviews) for all registered products – As per GMP requirements and evaluate any
possible trends.
• CAPA logging and management, arranging and facilitating the weekly to 3-monthly meetings required.
• Maintaining and improving the Quality Management System.
• Be part of the NPD (New Product Development) process and ensure that the SOP is followed which include the production of trial batches
and stability testing.
• Arrange and coordinate testing of products.
• Change Control managing and ensuring implementation on all levels.
• Compiling and updating of Master Formulation Sheets.
• Ensuring that master documentation is updated and current, approved and signed for all products.
• Annual inspections of local Contract Manufacturers, Contract Packers, Contract Printers, Wholesalers.
• Determining of training needs in QA.
• Acting as a catalyst for change and improvement in performance/quality.
• Supply information to the Regulatory Department to enable them to compile dossiers for registration or amend registered dossiers with new
product information.
• Performing Vendor/Supplier audits.

QUALIFICATIONS AND EDUCATION REQUIREMENTS:
? Qualified pharmacist registered with the South African Pharmacy Council.
? 3-5 years’ experience in the pharmaceutical industry with a demonstrable track record.

KEY COMPETENCIES
• Self-starter who can take initiative and work independently.
• Uncompromising attention to detail and accuracy.
• Ability to analyze and evaluate data.
• Excellent time management, planning and prioritization skills.
• Team player with a flexible approach.
• Strong interpersonal skills with a customer relationship focus.
• Good IT skills.
• Good communication skills (written and verbal).
• Action orientated / sense of urgency.
• Commercially astute.

Recruiter: Laz Badirwane