Regulatory & QA Manager (Responsible Pharmacist) Ceva Animal Health
CEVA ANIMAL HEALTH
Wednesday, 22 September 2021
Management - Other Management
Ceva Animal Health (Pty) Ltd is looking for a qualified Pharmacist to take the role of our Regulatory & Quality Assurance Manager. This person will also be the Responsible pharmacist of the Company.
Summary of position:
To maintain a Quality Management System compliant with GMP/GDP/GWP requirements. To ensure compliance of the pharmaceutical requirement as stipulated by SAHPRA.
Responsible to ensure that regulatory submissions and compliance are executed for all products in Ceva South Africa. Develop and communicate with our head office on the regulatory strategy and life cycle management of all products in the country. Represent Ceva within the local authority and other external partners.
At local level, provide and ensure quality oversight of activities in a defined scope (manufacturing / I&D). Managing a team of two employees.
● Must have Matric / Grade 12.
● B. Pharm degree.
● Registered with the Pharmacy council.
● Minimum 2 years Quality Assurance Management experience.
● Minimum 2 years’ experience as a Responsible Pharmacist in a Manufacturing
● Minimum 2 years’ experience in compilation and submission of Act 101 (MCC)
Dossiers, as well as Act 36 experience.
● CTD submission experience.
● Thorough understanding of GDP/GMP.
● MS Word, Excel and PowerPoint – intermediate to advanced skills required.
● High accuracy and attention to detail skills.
● Strong work ethic.
The following would enhance your position
• GDP/GMP Training / Certificate.
• Animal Health industry experience.
• Knowledge of regulatory submissions in Zimbabwe, Namibia&Zambia.
• Pharmaceutical Production knowledge.
• Act as Responsible Pharmacist for the entity.
• Regulatory Strategy & intelligence.
• Responsible for the Regulatory Plan and the successful execution thereof.
• Dossier preparation,compliance checks& submissions.
• LOQ Answer, submission & interaction with authorities.
• Maintenance & product life cycle management.
• Knowledge and intelligence management.
• Right level of quality & strategy.
• Quality Management System.
• Community building and activation.
• Audits& inspections.
Technical Skills required:
• Development and execution of regulatory strategy.
• Regulatory Affairs requirements and guidelines knowledge. (Animal Health specific)
• Technical Product development knowledge.
• Regulatory summary writing, registration dossier preparation & follow up.
• Networking & negotiation skills.
• Excellent Communication & presentation skills.
• Project management.
• Excellent IT & tool management skills.
• Previous audit experience.
• Technical & scientific knowledge.
• Continuous improvement of Processes & organisation.
• Regulation’s knowledge.
• Quality Management Systems.
• Excellent managerial skills, ability to effectively manage and lead change.
• Ability to anticipate & solve problems and queries.
Closing date for applications: 25 September 2021
Fax or e-mail applications to:
Contact: Elzet Rusch
CEVA ANIMAL HEALTH
CNR 16TH & DOUGLAS ROAD, RANJESPARK