Bryden pi - Quality Assurance Auditor

We are seeking to recruit a suitable candidate for the following position in the Operations Division:

                        Quality Assurance Auditor

The incumbent is required to assist in the maintenance of Bryden pi Limited’s QMS by determining the level of adherence to established procedures, requirements and standards through the application of auditing and evaluation techniques to the Company’s processes, products and services.

Some Main Responsibilities include: 

• Develop an annual audit plan for Bpi internal processes, ensuring focus on critical areas. 
• Schedule and execute internal audits of various processes as outlined in the approved annual audit schedule.
• Conduct unscheduled audits as directed by management and collaborate with process owners to address within the established timeframes.
• Maintain a masterlist of all internal audits and CAPAs and update to closure within established timeframes.
• Create and maintain both physical and electronic storage of Audit and CAPA documentation (Checklists, Worksheets, Reports and CAPAs).
• Log internal process CAPAs and investigate to determine the root causes
• Collaborate with process owners to ensure that internal audit CAPAs are closed on time and that corrective actions taken are effective, using appropriate tools and techniques
• Review corrective actions implemented to determine effectiveness and taking necessary steps if actions taken have not proven to be effective.
• Prepare an annual qualification and validation schedule for all temperature controlled spaces inclusive of delivery coolers.
• Assist in preparation of validation protocols and reports annually.
• Lead qualification and validation exercises for coolers and temperature controlled rooms/storage spaces.
• Develop an annual audit schedule for Bpi contractors.
• Conduct Bpi Contractor Audits in accordance with accordance with the approved contractor audit schedule
• Validate new SOPs to ensure they are robust and fit for purpose.
• Participate in improvement initiatives as required.

Qualification, Experience and Requirement: 

• Professional certification in quality assurance/internal quality audits/TQM and/or knowledge of ISO 9001; 2015, EU, WHO Technical Report Series and GxP Guidelines
• Associate’s Degree in Business Administration or equivalent.
• A minimum of two (2) years’ experience in a similar capacity.
  

Key Competencies:

• Good interpersonal and organizational skills
• Good organizational and solution-oriented skills
• Attention to detail and quality