Senior Quality Assurance Officeroutsource - Cape Town, South Africa - Biovac

Biovac

Verified Company

Cape Town, South Africa

2 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life".

We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Senior Quality Assurance Officer - Outsource to join a goal-oriented team.

QUALIFICATIONS NEEDED:

Degree or Diploma in Biotechnology, Pharmacy, Biological Sciences, or a similar field.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

At least 5 years' experience in Quality Assurance within the pharmaceutical/ biotech manufacturing industry.
Experience in quality management systems within a cGMP facility.
Sound technical ability in the field of Operational Quality Assurance.
Knowledge of supplier/vendor auditing advantageous

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Responsible for all QA Outsource Officer-related activities including but not limited to Artwork, Vendor management, and Outsource activities.
Ensure that the Vendor Management, Artwork, and Outsource sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
Compliance with all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining ways of working.
Coach and provide QA leadership to staff about vendor approval and certification.
Submit appropriate weekly, monthly, and quarterly, quality and operation metrics.
Write, review, and approve SOPs and Work instructions related to outsource section.
Ensure annual reports are completed where required.
Conduct vendor certifications, reviews, and approvals and manage the vendor database and AVL up to date.
Establish and maintain a riskbased approach and review of approved vendors by conducting quality risk assessments for approved vendors.
Plan, conduct, and coordinate internal audits including establishing audit teams, peer review of observations and following up with departments on open actions, writing the annual report for internal audits.
Plan, conduct, and coordinate external (supplier/vendor, customer, and thirdparty manufacturers) audits including establishing audit teams, peer review of observations, and followup of open vendor CAPAs and ensuring closure of audit findings.
Review and approve vendor postal audits.
Compile and review quality technical agreements for approval for suppliers/vendors, customers, and thirdparty manufacturers.
Create tracking mechanisms to manage all quality contracts for the department.
Compile and review contracts to all agents that Biovac exports to.
Coordinate regulatory audits, support QA Release and Outsource Manager Regulatory audits, and ensure that CAPA plans are in place and timeously executed for observation found.
Request master documents from thirdparty manufacturers.
Update the Site Master File as per regulatory requirements.
Manage and coordinate change notifications from vendors, 3rd party manufacturers.
Liaise with other support departments onsite to drive the change notifications from vendors, 3rd party manufacturers.
Create, coordinate, and manage artwork activities within Biovac.
Coordinate communication of artwork changes to thirdparty manufacturers.
Investigate and compile investigation reports relating to vendor quality complaints.
Communicate investigations and outcomes of vendor quality complaints to external state holders.
Coordinate vendor monitoring program and approve vendor monitoring reports.

_ Disclaimer:
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By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._