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Regulatory/Quality Manager |
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| Ref: 162 |
| Medical |
| Negotiable Per Month |
| Start Date: ASAP |
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QUALIFICATIONS AND EXPERIENCE
1. Minimum requirement
a. BSC Pharmacy essential
b. B Com Quality an advantage
c. Computer Literate, with Excel, Word, Powerpoint, Outlook
d. Minimum of 3 years experience in product registration and quality environment.
COMPETENCIES AND SKILLS
• Operate autonomously
• Leadership skill and problem solver
• Proactive and able to prioritise
• Ability to work under pressure and independently
• Analytical, creative, negotiation skills
• Ability to analyse makes wise decisions.
• Ability to write monthly reports
• Understanding of GMP, European Guidelines for Medical Gases.
MAIN DUTIES AND RESPONSIBILITIES
• Maintain Quality management system in Healthcare Organisation.
• Control and retain of registered medicinal products with MCC.
• Control, Maintain and Monitor ISO 9001 – 2008 International standard, IMS and Healthcare WBL Standards.
• Maintain and review the existing operating instructions and Implement Good Manufacturing Practices within medical filling stations inline with GMP guideline requirements.
• Maintain and control Quality and Regulatory documents and system within Healthcare.
• Follow up on new medicinal products registration with Medicines Control Council
• Conduct external quality audits in conjunction with AL (Pty) Quality personnel.
• Implement Standard Operating Practice (SOP) as required by Medicines Control Council (MCC) for GMP compliance and conduct GMP audits.
• Follow up on Branch Manufacturing licenses and distribution licence with MCC.
• Maintain accreditation, branch licenses and product registrations with external bodies within Healthcare.
• Do Monthly, Quarterly and Yearly quality and regulatory reports and present to Healthcare EXCOM, also to be presented to customers where applicable.
• Conduct product releases of all medicinal gases.
• Liaise with MCC, Registration Argent for status reports on registrations.
• Identify and implements the appropriate strategies which aim to improve the quality system of company.
• Attend all monthly working group meetings with other gas companies.
• Influences the Health care management team to adopt existing group quality system and maintain working instruction and procedures.
• Do a medical Air analysis to hospitals and give certificate for analyzed results and recommendation.
• Do a yearly budget for Regulatory and Quality department and other requirements.
• Part of new product development team focusing on assessment of quality.
• Implement and constantly update and review the product recall procedure.
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| CONTACT DETAILS |
Careerworx
0123483283
http://careerworx.co.za |
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