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| Company: |
Medico International Recruitment - MIR |
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| Job Title: |
Quality Officer |
| Job category: |
Pharmaceutical |
| Job Location: |
Mauritius |
| Job Description: |
A Quality Officer with experience in the pharmaceutical field is required for a healthcare organization in Mauritius
Purpose:
To manage all Quality related activities for the organization.
Define and executes strategy for quality assurance and compliance in operations.
Proactively drives compliance through implementation and monitoring of the organization`s quality standards, training and compliance tools.
Qualifications & Experience:
• 5 years pharmaceutical experience with at least 2 years in quality
• Science / medical degree
• Ability to handle multiple projects and bring them to completion in a timely manner
• Ability to challenge processes and standards and lead improvement initiatives as well as work with and influence manufacturing and analytical management, to improve standards of compliance and to meet expectations of quality standards
• Excellent written and verbal communication – fluency in English
Specific Outcomes / Accountability:
• Negotiate and finalize the Technical / Quality Agreements with affiliates and agents; manufacturing sites and any other institution where such an agreement is required;
• Ensure compliance of the various parties with the technical / quality agreements through desk audits and participation in the Audit matrix;
• Complete and maintain the Technical Terms of Supply per manufacturing site per product / market;
• Establish an SOP for regular assessment and updates;
• Attend to all the technical queries relating to the products (formulation, manufacturing, testing, packing est.) where such matters are purely of a quality nature;
• Co-ordinate all complaint related investigations;
• Evaluate batch records and documentation and ensure compliance with the regulatory filings - ensure any discrepancies are elevated and addressed;
• Manage Change Controls and approve where required - ensure Change Controls are linked through to the regulatory approval process and implemented post the required approvals;
• Compliance audits of all suppliers via desk audits and SOP’s;
• Attend to all quality matters relating to site transfers;
• Implementation of a quality management system as supplied by group in the organization and the global subsidiaries - this includes developing and implementing SPO’s for all practices within the various operations;
• Ensure deviations are recorded and adequately addressed at all sites;
• Evaluate proposed new manufacturing / packing / distribution sites prior to finalization of any manufacturing contracts and official audits;
• Maintain records of all relevant site approvals;
• Undertake site registrations of manufacturing / packing sites in countries requiring site registration;
• Elevate significant quality risks within the organization and put forward a risk mitigation strategy;
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Skills Required:: |
Qualifications & Experience:
• 5 years pharmaceutical experience with at least 2 years in quality
• Science / medical degree
• Ability to handle multiple projects and bring them to completion in a timely manner
• Ability to challenge processes and standards and lead improvement initiatives as well as work with and influence manufacturing and analytical management, to improve standards of compliance and to meet expectations of quality standards
• Excellent written and verbal communication – fluency in English
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Language Requirements: |
English-Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-04-15 |
| Level of Education: |
Unspecified |
| Years of Work Experience: |
No experience |
| Company: |
Medico International Recruitment - MIR |
| Contact Name: |
Medico International Recruitment - MIR |
| Contact Phone: |
04 361 29 25 |
| Preferred Method of Contact: |
No Preference |
| Preferred Language of Resume/Application: |
English |
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