Gmp Training Lead

2 weeks ago

Cape Town, Western Cape, South Africa DataTech Recruitment Full time

We are looking for a GMP Training Lead in Cape Town, who is dynamic, passionate, confident, proactive and meticulous, to join a goal-oriented team.

To provide coaching on training requirements and GMP needs to Managers and site. 6+ Years' experience in the pharmaceutical/ biotech manufacturing industry with 3+ years' experience in a Training Management/ Facilitation position. Experience in quality management systems within a cGMP facility.

Experience in Developing GMP training module example Cleaning room and Microbiology training material in the pharmaceutical industry, with experience in GMP Training Audits.

Strong Management and People skills required.

Responsibilities

  • Plan and coordinate GMP training activities and requirements according to project plans and site requirements.
  • Prepare, review and coordinate GMP training procedures, processes and systems.
  • Identify risks, investigate/ troubleshoot cGMP noncompliance issues.
  • Notify relevant department manager regarding issues of nonconformance and recommend corrective actions.
  • Provide coaching on training requirements and GMP needs to Managers and site.
  • Provide technical support for drafting of GMP modules along with Subject Matter Experts.
  • Source training material from external vendors.
  • Develop GMP training templates and customize training material where required.
  • Submission of monthly reports and feedback on effectiveness of training.
  • Risk mitigation plans for staff who are not 'licensed' to perform their work functions due to failed assessments.
  • Ensure that all GMP training audits are successful in with Standard Operating Procedure requirements.
  • Continuous improvement of the training system in line with industry trends and cGMP.
  • Overall accountability for the Track wise Training System.

Requirements:

  • Tertiary Qualification in Microbiology/ Biotechnology/ Life Science/ Pharmacy or equivalent.
  • At least 6 years' experience in the pharmaceutical/ biotech manufacturing industry.
  • At least 3 years' experience in a Training Management/ Facilitation position.
  • Experience in quality management systems within a cGMP facility.
  • Experience in Planning, Coordinating and Facilitating GMP training
  • Experience in Developing GMP training module example Cleaning room and Microbiology training material in the pharmaceutical industry
  • Experience in conducting Induction for new starters and site wide GMP training example Production and Quality Control sterile training
  • Experience in GMP Training Audits
  • Leadership ( middle management role) ability to engage with stakeholders and coordinate a training program
  • Strong people skills, and ability to engage in various "new" areas of the business
The company offers very competitive rates.

Job Types:
Full-time, Permanent

Salary:
R650, R703,872.00 per year

Education:

  • Diploma (required)

Experience:

- pharmaceutical/ biotech: 6 years (required)
Training Management: 3 years (required)

  • Facilitating GMP training: 2 years (required)
  • Developing GMP training: 2 years (required)
  • GMP
Training Audits: 2 years (required)

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