Export RA Pharmacist - Johannesburg
DIVISION : PHARMA
• Assistance with dossier registrations in the African countries and collate all the data needed
• Maintain registration documentation ensuring compliance with relevant legislation.
• Provision of technical information and registration support to all relevant departments.
• Review and approval of new and amended documentation.
• To create, update, submit and maintain product dossier registration documentation in accordance with the applicable regulations which includes translating regulatory requirements into practical, workable submission plans and to develop and maintain timelines.
• To collect all the information/specifications required for dossier compilation.
• To provide thoughtful and accurate comments during document review mindful of regulatory requirements in each individual country.
• To develop and maintain current regulatory knowledge.
• To acquire published new or amended acts, regulations, bills and notices relevant to the pharmaceutical industry in African countries.
• Reviewing all master documentation sent for approval by third party manufacturers.
• To initiate and facilitate change control requests and maintain the Change Control Register.
• To ensure that Quality standards are maintained and propose improvements.
• Assist with the adverse drug reaction and pharmacovigilance process for the African countries within the Regulatory Department
• To supervise regulatory support staff when required.
• To be able to apply for permits, CoPP’s and GMP certificates to be issued by SAHPRA, when needed for submission in the other African countries.
• To liase with country agents and Regulatory Authorities
• Ensuring compliance with statutory regulatory and quality requirements
• Monitor trend analysis on non-compliance and taking corrective and preventative actions
• To lead and control the quality assurance functional activities
• Preview and approve all contracts from suppliers and ensure compliance in their contracts
• To co-ordinate quality management systems in line with regulations and company goals
• To track, analyze and investigate customer complaints and ensure implementation of preventative measures
EDUCATION AND KEY EXPERIENCE
• B.Pharm / Equivalent technical degree
• Experience in pharma environment – advantageous 5-10 years' experience in the pharmaceutical industry (Production/Quality Assurance/Regulatory)
• Good knowledge of MS Office (Excel, Word, Adobe Pro, Power point, Docubridge etc.) and Outlook.
• Attention to detail
• Self-motivated individual
• Ability to work under pressure and coSmplete tasks against deadlines
• Excellent written and verbal communication skills
• Excellent communication and interpersonal skills within a team context
• Ability to multi-task and handle a few tasks simultaneously
Should you not receive any correspondence within two weeks of submitting your application, please
Consider your application unsuccessful.
CLOSING DATE: 11th September 2019