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QC Equipment Specialist

QC Equipment Specialist

BiovacCape Town, Western Cape, South Africa
30+ days ago
Job 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 QC Equipment Specialist to join a goal-oriented team.

QUALIFICATIONS NEEDED :

  • Diploma / Degree in Microbiology / Biochemistry / Chemistry or equivalent.
  • Recognition is given to Prior Learning and practical experience.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE :

  • At least 5 years of QC Laboratory exposure related to equipment maintenance / calibration / troubleshooting experience.
  • Experience in quality and regulatory compliance within a cGMP in Sterile / Vaccine facility.
  • Participation in monitoring expenditures for Expense Budgets and Capex related costs.
  • KEY DUTIES & RESPONSIBILITIES OF THE ROLE :

  • Manage the execution of all laboratory equipment, sourcing, qualifying, maintenance, calibration, compliance activities and adherence to specified timelines, including any deviations to work schedules.
  • Ensures the repair of laboratory equipment timeously according to policies and procedures.
  • Facilitate interaction with QC laboratory management team to ensure equipment is maintained and calibrated according to procedures, on time and available for use.
  • Escalate all failures to the QC management timeously.
  • Oversee contractors in the execution of activities.
  • Monitor contractor adherence to SLA and KPIs.
  • Manage resources to execute plans and monitor schedule compliance.
  • Ensure safe and efficient execution of required activities.
  • Enforce legal compliance of maintenance operations.
  • Ensure tools, assets, controls are within required guidelines and standards.
  • Ensure stock levels are maintained to prevent out-of-stock situations.
  • Ensure weekly routine maintenance schedule is executed as planned / scheduled.
  • Ensure continual compliance of laboratory standards and SOPs to latest pharmacopeial, and regulatory compliance.
  • Continually improve and optimize work processes.
  • Performance management of direct reports.
  • Provide input into operational planning and prioritization of section objectives.
  • Provide input into, interpret and execute policies and procedures.
  • Provide input into and manage budgets & resource requirements for section.
  • Ensure Capex management for the QC laboratory equipment is based on needs and business objectives.
  • Participate in development of work schedules.
  • Participate in sourcing (URS / UB), purchasing, receipting DQ / IQ / OQ / PQ of all new equipment.
  • Participate in all requalification activities with support functions.
  • Actively Participate in Laboratory investigations and problem solving where equipment is impacted.
  • Ensure that all data generated are reviewed and released according to cGMP and data integrity policies and procedures.
  • Ensure all documentation generated is retained and easily available during audits.
  • Provide daily coaching and supervision for technicians / analysts.
  • Perform maintenance / calibration / trouble shooting on all QC Laboratory Equipment.
  • Liaise with QC Laboratory and Engineering to ensure that the maintenance plan is accommodated.
  • Liaise with suppliers during trouble shooting / OOS / OOT on all laboratory equipment in attempt to find and correct root causes.
  • Co-ordinate problem solving and priorities execution of tasks.
  • Provide input for improvement of risk-based compliance systems.
  • Monitor implementation and correct own and / or team compliance with the current regulations and guidelines - both local and international.
  • Application Deadline : 31 July 2025

    If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

    Disclaimer :

    Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

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    Equipment Specialist • Cape Town, Western Cape, South Africa

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