QA Outsource Specialist

BiovacCape Town, ZA

13 days ago

Job description

Job title : QA Outsource Specialist

Job Location : Western Cape, Cape Town

Deadline : November 16, 2025

Quick Recommended Links

Jobs by Location
Job by industries
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 QA Outsource Specialist to join a goal-oriented team.

QUALIFICATIONS NEEDED :

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

Audit Certification from an internationally recognized service provider.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE :

At least 3-5 years of experience in the pharmaceutical / biotech manufacturing industry doing activities related to vendor management.

At least 2-5 years in Aseptic manufacturing.

Sound technical ability in the field of operational Quality Assurance.

Experience in quality and regulatory compliance within a cGMP facility.

Quality and Regulatory compliance knowledge, i.e., SA GMP, PIC / S, and WHO as well as application

Business and operational planning.

Program and project management

Experience having performed local and international audits.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE :

Core Technical Delivery :

Plan, schedule, and perform audits of sterile manufacturing facilities, equipment, processes, and systems.

These audits may include but are not limited to sterile manufacturing facilities, drug substance facilities, aseptic processing, cleanrooms, and controlled environments. Assess compliance with relevant regulations (e.g., PIC / S, WHO, FDA, EMA, GMP, ICH), company policies, and industry standards.

Identify areas of non-compliance, potential risks, and opportunities for improvement during audits.

Collaborate with relevant stakeholders to develop corrective and preventive action plans (CAPAs).

Prepare comprehensive audit reports summarizing findings, conclusions, and recommendations for management and stakeholders.

Stay up to date with changes in regulations and guidelines related to the pharmaceutical industry.

Collaborate with procurement to conduct audits of vendors, suppliers, and contract manufacturers to ensure their compliance with quality and regulatory requirements.

Specialize in GMP guidelines and good practices within Aseptic manufacturing and provide technical support to other Quality units.

Provide technical feedback on audit observations in the quality space to align with good practices.

Provide Technical support to the QA Officers related to international standards, regulations, and guidelines.

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 with regard to 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.

Review and approve vendor certifications and manage the vendor database and AVL up to date.

Responsible for maintaining a risk-based approach by reviewing new and approved vendors by conducting vendor quality risk assessments.

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 third-party manufacturers) audits including establishing audit teams, peer review of observations, and follow-up of open vendor CAPAs and ensure closure of audit findings.

Escalate any significant / critical observations to the QARO manager and Head of Quality.

Responsible for the coordination of regulatory audits, by planning and supporting the Head of Quality and the Responsible Pharmacist during Regulatory audits and ensuring that CAPA plans are in place timeously.

Review and approve vendor postal audits.

Create an audit committee to review audits performed on CMOs.

Compile and Review quality technical agreements for approval for suppliers / vendors, customers, and third-party manufacturers.

Compile and review contracts for Agents that Biovac exports to.

Ensure that vendors change notifications from vendors, 3rd party manufacturers are communicated to the site.

Liaise with other support departments on-site to drive the change notifications from vendors, 3rd party manufacturers.

Coordinate communication of artwork changes to third-party manufacturers.

Investigate and compile investigation reports relating to vendor quality complaints.

Communicate investigations and outcomes of vendor quality complaints to external stakeholders.

Review and approve vendor monitoring reports.

Production / Manufacturing jobs

Create a job alert for this search

Specialist • Cape Town, ZA

Related jobs

Promoted

Technical Quality Assurance Specialist

Longdue GamesWorkFromHome, Western Cape, South Africa

Technical Quality Assurance Specialist – Longdue Games.Technical Quality Assurance Specialist.Longdue is an independent narrative game studio incubated within HyperionDev.We create psychologically ...Show moreLast updated: 12 days ago

Promoted

Technical Quality Assurance Specialist

HyperionDev CorpWorkFromHome, Western Cape, South Africa

HyperionDev is one of the largest providers of accelerated tech education in EMEA and one of the oldest providers of 'coding bootcamps' in the world. We work with top universities such as Imperial C...Show moreLast updated: 15 days ago

Promoted

Specialist, Quality Assurance

TeleTech Holdings, Inc.Cape Town, Western Cape, South Africa

Bringing smiles is what we do at TTEC… for you and the customer.Quality Assurance (QA) Specialist.TTEC, an award‑winning employment experience and company culture. Looking for an opportunity to be p...Show moreLast updated: 10 days ago

Promoted

Quality Assurance Specialist

Smart PAWorkFromHome, Western Cape, South Africa

Permanent employee, Full-time • South Africa - REMOTE • 200,000 - 450,000 R per year.At SmartPA, we transform support by redefining administrative and PA services through innovative thinking, techn...Show moreLast updated: 27 days ago

Promoted

Intermediate QA Analyst

WatersEdge SolutionsStellenbosch, South Africa

Remote (South Africa-Based, with Quarterly In-Person Team Events in Stellenbosch).SaaS | Digital Product Development | Quality Assurance. WatersEdge Solutions is hiring an analytical and detail-orie...Show moreLast updated: 30+ days ago

Promoted

QA Manager

LulaCape Town, Western Cape, South Africa

ALL STAFF APPOINTMENTS WILL BE MADE WITH DUE CONSIDERATION OF THE COMPANY’S EE TARGETS.Lula is an innovative and human-focused FinTech company on a mission to help small businesses optimise their c...Show moreLast updated: 30+ days ago

Promoted

QA Specialist (Software Tester)

Communicate RecruitmentCape Town, South Africa

Join a team crafting software that tracks agricultural goods from farm to port.Youll test platforms like Palbroker, covering logistics, financials, and dashboards. Expect manual and automated testin...Show moreLast updated: 30+ days ago

Promoted

Supply Chain Quality Controller

Status StaffingStellenbosch, South Africa

A recent professional profile photo is to accompany your application.EMPLOYMENT TYPE : Permanent.SECTOR : Supply Chain / Quality Control.BASIC SALARY...Show moreLast updated: 3 days ago

Promoted

QA Engineer Ref : 4060

NDC PersonnelCape Town, South Africa

To be considered for this role, you should have a minimum qualification of Matric with Mathematics, with tertiary education in BEng and / or Industrial Engineering. You should have 10-20 years of expe...Show moreLast updated: 14 days ago

Promoted

Specialist Services Engineer (Tier 3)

PRR RecruitmentBellville, South Africa

Specialist Services Engineer (Tier 3).Are you a senior IT professional with deep technical expertise and a track record of successful project delivery? A high-performing team in Bellville is lookin...Show moreLast updated: 6 days ago

Promoted

Recruitment Specialist

Dante PersonnelCentury City, South Africa

Tertiary qualification advantageous.Years experience within Sales, Administration or Recruitment.Able to execute daily cold calling. Screening and sifting through CV's.Positive and proactive attitud...Show moreLast updated: 6 days ago

Promoted

Quality Assurance Specialist

RareCruitCape Town, South Africa

The Quality Assurance Specialist ensures that all software products delivered to clients are reliable, user-friendly, and compliant with industry standards. Delivering consistently high-quality rele...Show moreLast updated: 16 days ago

Technical Specialist

Boardroom AppointmentsCape Town, Western Cape, South Africa

Quick Apply

Technical Specialist - Cape Town.Deploy, configure, and support.IaaS, BaaS, and DRaaS solutions.Provide proactive monitoring, troubleshooting, and resolution of incidents.Implement backup, rec...Show moreLast updated: 30+ days ago

Promoted

QA Capability Manager

Datonomy SolutionsCape Town, South Africa

We are seeking a QA Capability Manager, based in Cape Town.Initial 12-month contract, onsite.The QA Capability Manager will be responsible for overseeing the quality engineering strategy across mul...Show moreLast updated: 8 days ago

Promoted

Quantum Specialist

Communicate RecruitmentStellenbosch, South Africa

Quantum Algorithm Design : Developing solutions that leverage superposition.Quantum Hardware Proficiency : Experience with IBM Quantum, Rigetti, IonQ, or D-Wave systems. Quantum Software Mastery : Qisk...Show moreLast updated: 10 days ago

Promoted

Hubspot Integration Specialist - 16034

SomewhereWorkFromHome, Western Cape, South Africa

HubSpot Integration Specialist - 16034 at Somewhere.Team : RevOps / Marketing Ops × Engineering.We’re eliminating single-point-of-failure risks across our RevOps stack. You’ll be the internal backup ...Show moreLast updated: 5 days ago

Promoted

QA Engineer

Persona StaffCape Town, South Africa

Product Testing & Analysis.Conduct root cause and failure mode analyses on product non-conformances.Develop and implement corrective and preventative action (CAPA) plans.Perform in-depth produc...Show moreLast updated: 15 days ago

Promoted

CAD Specialist (Retail)

Southey ContractingCape Town, South Africa

The Junior CAD Specialist will assist in the creation, modification, and preparation of detailed 3D CAD models and 2D technical drawings used for product development and manufacturing.You will play...Show moreLast updated: 21 days ago