Job Posting Info (Pick any 3 sites for $125 - 120 days, e-mail: Sastha.com, Inc. Call: 313-882-3776) Submit your Job Posting I NicheJobs.com Summary.pdf I Add Resume
Date Posted: 12/11/14
Quality Assurance Operations Section Head
Quality Assurance Operations Department
Pinelands, Cape Town
The Biovac Institute requires a Quality Assurance Operations Section Head to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbent will report to the Quality Assurance Operations Manager
The Key Performance Areas for this position include:
o Participate in the investigation of deviations, discrepancies or test failures:
o Ensure compliance to quality systems are monitored via QCF departmental meetings
o Ensure monthly Quality Council metrics is submitted timeously
o Write and submit annual quality management system review report to senior management.
o Review and approve quarterly metrics reports
o Evaluate and assess the vendors suitability through vendor certification process and by conducting site audits where applicable (technical assessments), including quality systems or assessing appropriate vendor GMP checklist responses and ensure all necessary information is received to enable the material or service to be used on site.
o Audit and approve contract manufacturers, where these are to be employed
o Ensure new vendors are placed on audit plan and vendor audits conducted as per audit plan; Unsatisfactory vendors removed
o Participate in projects as/when required
o Ensure Projects deliverables delivered as per agreed timelines and quality
o Delegate project deliverables to staff in section where appropriate according to skill or skill development
· Budgeting & Expense Management:
· Identify departmental risks and mitigate where appropriate.
· Innovation and Improvement initiatives and projects
Qualifications and Skills Required:
· Degree or Diploma in Microbiology / Biotechnology, Pharmacy or equivalent.
· 5 years experience in vaccine / biotech / pharmaceutical industry or equivalent would be advantageous.
· 3 years supervisory / management experience in cGMP vaccine manufacturing / or similar position.
· Sterile experience will be an advantage
· Quality & regulatory compliance knowledge, i.e. MCC and WHO.
· Experience in general business management.
· Sound technical ability and hands on approach.
· Experience in having faced successfully local and international quality audits.
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the
pursuit of excellence, diversity and redress.
Interested persons to kindly submit their CVs to email@example.com
Global Job Search
Refer to http://www.NicheJobs.com when applying for this job
Copyright Sastha.com, Inc., All Rights Reserved.