Company

Ich GcpSee more

addressAddressBrisbane, QLD
CategoryGraduate Training & Internships

Job description

Pharmaceutical Product Development (PPD)

Brisbane, Queensland, Australia

Job Description

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Position Summary:

Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMA, ICH etc. Reporting to the Head of Quality, this position is responsible for the oversight, management development and implementation of the sites GMP training system.

As a member of the site Quality Leadership Team (QLT), the Training Lead supports the entire site management team through the orchestration of the staff Training System including reporting, compliance documentation, optimization and system change strategy & management and learning and development. The role also works with the global Training team. The Training Lead coaches, mentors and develops direct reports and other departmental staff who support training administration including training needs assessments, training development and delivery, and learning management system administration.

If this sounds like you, we'd love to hear from you!

Key Responsibilities:
  • Development, management and maintenance of the site Training program/system, policies and procedures
  • Collaboration with corporate training resources to ensure that Site Training program is aligned with corporate strategy and expectations
  • Stay abreast with industry trends as it relates to training and adopt/ implement industry best practices
  • Reporting of Training compliance/ performance and status and metrics to Site Management Team, Site Leadership Team and Corporate Management
  • Direct engagement with regulatory agencies and customer/clients to represent the compliance of the Training System
  • Assist with onboarding of new hires
  • Training of Quality and Manufacturing personnel in the principles and application of cGMP pertaining to work that supports cGMP manufacturing
  • Collaborate with line managers to develop required training curricula including technical, managerial, soft skills and external continuing educational programs as required
  • Promoting a culture of training and learning across the site
  • Leadership in developing, implementing and maintaining Quality Systems
  • Developing and approving training materials
  • Lead, coach, mentor and develops direct reports
  • Support quality system initiation/review/approval (support deviation investigations, CAPAs, change controls, etc.) as required
  • Data entry, records management and general administration of the LMS as required

Frequent Contacts:

Internal

Quality, operations, supply chain, engineering, global quality

External

Regulatory authorities, customers/clients, consultants/contractors

Minimum Requirements/Qualifications:

Qualifications & Experience:

5-10 years' experience in Workplace Training and Assessment or equivalent work experience

Prior supervisory/leadership experience preferred

Prior experience in pharmaceutical/bio pharmaceutical industry preferred

Skills & Attributes:

Proven track record to thrive in a fast-paced and dynamic working environment.

Excellent oral and written communication skills, as well as interpersonal skills.

Other Important Information

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Job posted: 2024-03-01

Refer code: 1778933. Ich Gcp - The previous day - 2024-03-17 14:58

Ich Gcp

Brisbane, QLD
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