Qc Lead Micro

6 months ago

Cape Town, South Africa Biovac Full time

**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 QC Lead Micro & Biological Testing to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Degree or diploma in Microbiology / Biochemistry/Biotechnology or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 5 years of experience in the sterile vaccine/pharmaceutical/biotech manufacturing industry
- At least 2-3 years of experience at the supervisory level.
- Experience in quality and regulatory compliance within a cGMP facility.
- Technical knowledge of aseptic practices and Microbiological/Biological methods.
- Strong knowledge of sterile manufacturing environment
- Experience in having faced successful local and/or international quality audits.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Drive continuous improvement plans and priorities through the implementation of appropriate tools or methodologies to proactively manage risk, reduce wastage, and improve quality on site.
- Manage approval of laboratory raw data and investigation of out-of-specification results where applicable (Micro & Biological).
- Manage the compilation of analytical method validation/ verification protocols and reports.
- Manage the compilation review, approval of user requirement specification and/or user briefs, qualification documents, CAPEX approval, Risk Assessment, Change Management, and implementation of new and updated equipment and software.
- Manage the selection and procurement of analytical test equipment and participation in equipment qualification, (Micro & Biological).
- Manage the execution of project activities according to agreed project timelines.
- Manage Sampling and testing and release of starting materials (e.g., raw materials, production devices, and packaging materials) used in production processes.
- Manage Micro & Biological testing of intermediate and finished product testing as per product specifications.
- Manage visual inspection activities of in-process and final products as per the required SOPs and product specifications related to vaccines and packaging activities.
- Manage the review of analytical method validation/ verification protocols and reports and coordination with a focus on Micro & Biological testing.
- Maintaining that Stability Program, including compiling stability protocols and reports, related to Micro & Biological testing.
- Participation in project teams as a QC representative.
- Ensure that Micro & Biological testing is performed according to the Biovac Stability Program. Assist with the compilation of stability protocols and reports.
- Manage the transfer of analytical methods from technology transfer partners to Biovac and their implementation in the laboratory, with a focus on Micro & Biological testing.
- Manage the writing and updating of material and product test methods and standard operating procedures.
- Manage Data Integrity in the QC Laboratory with reference to Micro & Biological along with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when available.
- Liaise with suppliers on technical issues where applicable.
- Manage training, coaching, and competency assessment of Micro & Biological staff to approve procedures and protocols.
- Participate in quality audits and close any gaps in findings.
- Ensure that OOS and OOT investigations are initiated and completed to the correct standard within the required due dates.
- Participate in inspections, investigations, risk management, and quality review exercises.
- Execute project activities according to agreed project timelines and within cGMP requirements.
- Manage the Operational Expense (OPEX), Capital expenditure (CAPEX), cost control, and budgeting for the Micro & Biological department in conjunction with the QC Manager.
- Participate in significant Micro & Biological investigations that can impact product Quality and patient safety.
- Lead significant Micro & Biological Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).
- Lead engagement with external third-party stakeholders (e.g., Pfizer and Sanofi) regarding Micro & Biological areas.
- Provide technical guidance to QC teams and to other stakeholders within the business from a Micro & Biological perspective.
- Manage the review and approval of significant documentation within the Micro & Biological team as defined within local procedures.
- Manage the Environmental monitoring program, for the site and ensure that it meets cGMP requirements.
- Manage Environmental Monitoring data analysis and reports are provided to stakeholders.
- Provide specialist support for GMP cell banks and work with Science & Innovation (S&I) team to transfer cell bank knowledge into the Microbiology/Biochemistry department.
- Review and approve significant documentation w

  • Micro Technician

    4 weeks ago

    Stellenbosch, Western Cape, South Africa Heineken International B.V. Full time

    We Go Places! How about you? Immediate Superior: Wandile Gqweta Location: Stellenbosch Type of Contract: Permanent Reference Number: 124446 Closing Date: 15/11/2024 Key Performance Areas include (but are not limited to): - Align goals and objectives with site quality - Manage Micro lab - Manage equipment reliability - Manage and optimise current lab...

  • Lead Developer

    1 week ago

    Cape Town, Western Cape, South Africa Kazang a company part of the Lesaka Technologies Group Full time

    About the RoleWe are seeking an experienced Lead Developer to join our micro-merchant division at Kazang, part of the Lesaka Technologies Group. This is a key position within our development team, responsible for driving technical direction and ensuring the delivery of high-quality software solutions.Job DescriptionTechnical Leadership:Leveraging Technical...

  • Micros Hospitality Systems Consultant

    5 months ago

    Cape Town, South Africa AdaptIT Full time

    **Listing reference**: adapt_000118**Listing status**: Online- **Position summary** **Industry**:IT & Internet - **Job category**:Hospitality, Hotel, Catering, Tourism and Travel**Location**:Cape Town - **Contract**:Permanent**EE position**:No**About our company** - A provider of leading specialised software and digitally-led business solutions that assist...

  • Field Technician-micros Cape Town

    6 months ago

    Cape Town, South Africa AdaptIT Full time

    **Listing reference**: adapt_000126**Listing status**: Online- **Position summary** **Industry**:IT & Internet - **Job category**:Hospitality, Hotel, Catering, Tourism and Travel**Location**:Cape Town - **Contract**:Permanent**EE position**:No**About our company** - A provider of leading specialised software and digitally-led business solutions that assist...

  • Nace Qc Level 1 Inspector

    3 months ago

    Cape Town, South Africa Webmech Pty Ltd Full time

    We are seeking a skilled NACE QC Level 1 Inspector to join our team in Cape Town. This role involves ensuring that all inspection processes and quality standards are adhered to, contributing to the successful delivery of projects. **Key Responsibilities**: - Conduct inspections and quality control checks in accordance with NACE QC Level 1 standards. -...

  • Lead Assistant Manager

    6 months ago

    Cape Town, South Africa Believe Resourcing Full time

    Lead Assistant Manager - Quality Excellence Cape Town CBD Full time **About our client: Our client is a global analytics and digital solutions company serving industries including insurance, healthcare, banking and financial services, media, retail, and others. **Why should you choose our client? Joining them means surrounding yourself with some of the...

  • Quality Assurance Specialist

    7 days ago

    Cape Town, Western Cape, South Africa HR Genie Full time

    Job DescriptionAs a Quality Assurance Specialist at HR Genie, you will play a vital role in ensuring the highest quality standards are met in our manufacturing process.Responsibilities:Verify scales and incubators on a daily basis to ensure accuracy and precision.Conduct thorough inspections of packaging to ensure compliance with specifications.Test...

  • Quality Assurance

    6 months ago

    Cape Town, South Africa PIE IN THE SKY, MONTAGUE GARDENS CAPE TOWN Full time

    **Quality Assurance & New Product Development Officer** **Purpose of the role**: In close liaison with the Quality Manager and the Quality team translate the Qualiity policies and procedures into Standards Operating Procedures (SOPs), as part of a systematic & systems-based approach that serve 1. the assurance of quality within a coherent system, 2. the...

  • Solar Lead Installation Electrician

    6 months ago

    Cape Town, South Africa Staff Solutions Full time

    **Western Cape**, Cape Town** **Monthly Basic Salary (Market related, Negotiable)** NEW VACANCY ALERT! An opportunity has arisen with our client in the renewable energy industry for a Solar Lead Installation Electrician, to be based at their branch in Cape Town. **Duties**: - Liaise with Technical Support Manager to review project plans and drawings and...

  • Quality Manager

    6 months ago

    Cape Town, South Africa Mass Staffing Projects Full time

    **Job Information** - Location- Cape Town- Salary- R1.1mil - R700k- Job Type- Permanent- Education- BEng/BSc Engineering- Experience- 5 - 15 years- Reference- TL0904QMRD- - engineering.jobs(at)staffingprojects.co.za- Fax- 0867182241A leading International IPP is looking for a Quality Manager to lead the QA/QC Team to manage the quality of works on a utility...

  • Team Lead Systems and Architecture

    5 months ago

    Cape Town, South Africa Interviewing Dynamix Full time

    **Team Lead Systems and Architecture** Are you a passionate and experienced Back-End Engineer who wants to do meaningful and impactful work, in shaping the future of IoT integration and connectivity in South Africa? **Our client** A pioneering IoT company, specialising in professional connectivity solutions where their core focus is on managing...

  • Quality Control Lead

    5 months ago

    Cape Town, South Africa Unique Personnel Full time

    **Job Number** - 72593 **Job Type** - Permanent **Job Title** - Quality Control Lead **Computer Skills** - Microsoft **Industry** - Engineering **City** - Cape Town **Province** - Western Cape **Job Purpose**: - The QC Lead role is required Advocates and supports the Corporate WIN Strategy by managing the quality operations; Develops, modifies,...

  • Quality Site Manager

    5 months ago

    Cape Town, South Africa Talent Acquisition Consulting Full time

    We have an exciting opportunity for a Quality Site Manager to join our client within the renewable energy sector. The main purpose of this position is to interact and hold responsible all EPC quality workstreams to deliver installations on schedule within engineering specifications, accepted and signed off on time by suitably qualified inspectors. **You...

  • Quality Assurance and Compliance Specialist

    2 days ago

    Cape Town, Western Cape, South Africa Oxyon Human Capital Solutions Full time

    About the RoleWe are seeking an experienced Quality Assurance and Compliance Specialist to lead our EPC project team. As a key member of our team, you will be responsible for ensuring that all projects meet the highest standards of quality and compliance.Key ResponsibilitiesTo develop and implement quality management plans to ensure that all projects meet...

  • Junior Quality Manager

    5 months ago

    Cape Town, South Africa JSM Business Services Full time

    Our client, a leading engineering firm specialising in plastic injection systems, wants to appoint a Junior Quality Manager at their plant in Epping, Cape Town, who will report to the Quality Manager and/or Director. The person will be responsible for ensuring that the Quality Control system, within a specific department of the company, functions optimally...

  • Software Engineering Team Lead

    1 month ago

    Cape Town, Western Cape, South Africa Lula Full time

    Job Title: Technical Lead for Software EngineeringWe are seeking an experienced Technical Lead for Software Engineering to join our team at Lula, an innovative and human-focused FinTech company. As a Technical Lead, you will be responsible for leading a cross-functional team of software engineers in the delivery of our platform and business bank. Your...

  • Project Engineering Lead

    6 months ago

    Cape Town, South Africa Scatec Full time

    Overview: Want to join an innovative player in renewable energy that is rapidly growing in Africa? Since it was established in 2019 as part of renewable energy frontrunner Release by Scatec has been developing and deploying a unique, flexible leasing solution of pre-assembled and modular solar and battery equipment for the mining and utilities market....

  • Quality Control Technician

    2 weeks ago

    Cape Town, South Africa HR Genie Full time

    Accountable for specialist outputs, as well as initiating quality standards within defined work routines and policies.Job PurposeTo ensures effective quality control through the verification of scales and incubators, execution of the manufacturing start up procedure, efficient packaging analysis and inspections.Key Accountabilities and OutputsVerifications...

  • Developer

    7 months ago

    Cape Town, South Africa Graylink Full time

    We're looking for a talented developer to join our high performance team to work on our market leading cloud-based software solutions.The ideal candidate has strong javascript skills, functional programming capability, and experience in developing cloud hosted web applications, either from scratch or by migrating legacy MS .NET systems to a more modern JS...

  • Lead Python Software Engineer

    2 weeks ago

    Cape Town, Western Cape, South Africa Lesaka Technologies Full time

    Senior Python Engineer Opportunity at Lesaka Technologies,We are excited to announce a vacancy for a Senior Python Engineer to join our growing development team in Century City, Cape Town. This is an excellent opportunity for a talented software engineer to drive innovation and contribute to the success of our Micro Merchant Division.About the Role:As a...