Regulatory Affairs Pharmacist
Taylored Appointments
- R58,300 - R75,000 per month
- Permanent Management position
-
Midrand
- Posted 27 Apr 2024 by Taylored Appointments
- Expires in 21 days
-
Job 2564918
About the position
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 the company. Develop and communicate with our head office on the regulatory strategy and life cycle management of all products in the country. Represent the company 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 one employee.
Minimum Requirements:
- Must have Matric / Grade 12.
- Pharm degree.
- Registered with the Pharmacy council.
- Must be computer literate (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 and will be an advantage:
- Previous Quality Assurance Management experience.
- Experience as a Responsible Pharmacist in a Manufacturing environment.
- Experience in compilation and submission of Act 101 (MCC) Dossiers, as well asAct 36 experience.
- Thorough understanding of GDP/GMP will be an advantage.
- Animal Health industry experience.
- Knowledge of regulatory submissions in Zimbabwe, Namibia & Zambia.
- Pharmaceutical Production knowledge.
- Experience in compilation and submission of Act 101 (MCC)Dossiers, as well as Act 36 experience.
- CTD submission experience will be an advantage.
Main Accountabilities:
- 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& strategy.
- Community building and activation.
- Responsible for Pharmacovigilance.
- Audits & inspections.
Desired Skills:
- Quality Assurance Management
- responsible pharmacist
- Attention to detail
- GDP/GMP
- Act 101 (MCC)
Desired Work Experience:
- 2 to 5 years [other] Medical
- 5 to 10 years Pharmacist
Desired Qualification Level & Accreditations:
- Degree
- South African Pharmacy Council
Taylored Appointments
About the agency
TAYLORED APPOINTMENTS provides an integrated approach to staffing and succession planning, finding solutions that ensure both candidate and client benefit from the process. We are a full service recruitment and HR outsourcing company
TAYLORED APPOINTMENTS is a specialist recruitment agency. Located in Studio Park in Johannesburg’s Northern Suburbs. Established in October 2008 by a dedicated team committed to delivering an integrated quality service to both clients and candidates. The company rebranded in 2011 and incorporated the “HR OUTSOURCE” service which has been well received by a number of clients.
TAYLORED APPOINTMENTS is a dynamic team of seasoned professionals, where fresh thinking, client knowledge and in-house quality control, offers a company that is as passionate about client success as service delivery.
TAYLORED APPOINTMENTS has a successful network and database of top level candidates and undertakes continued proactive innovative search for leadership and skills. Our effective and ambitious sourcing campaign produces excellent results.
OUR PHILOSOPHY
Our belief is best service, best information, best value and best return on investment...
Your people
TAYLORED HR OUTSOURCED CLIENTS
Includes an extensive network of companies, assisting them to identify best HR practices and source best accounting and finance professionals for key positions within their organisations. Our role is to enhance the value of our clients’ operations, we do this by systematically indentifying and attracting the candidates that add to the reputation of our client and own good name. HR services include
• Strategic Intervention
• Job Evaluation
• Alignment of People Strategy with Operational Strategy
• Employee Relations Management
• Appraisal System
• Payroll Management for selected clients
Everyone know that what gets measured gets done!
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