When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
How will you make an impact?
in this role you will monitor and direct training activities, develop training material, lead training sessions, create training metrics and support Deviation Reports/CAPA initiatives within the operations department.
What will you do?
Standard Operating Procedures (SOPs) & Hands-On Training
- Review, revise and prepare procedures/SOPs for compliance to Good Manufacturing Practices and to reflect current work activities in Operations department
- Ensure procedures/SOPs for Operations department are of sufficient detail for technical content, accuracy, clarity, completeness, and flow. In particular, procedures in response to Bi-Annual Reviews, DRs, comments/audits by clients and regulatory agencies, change controls (CCs), new/modified equipment, and general changes in procedures
- Ensure procedures/SOPs are regularly reviewed and kept up to date with proper approvals
- Work closely with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided
- Develop training material and lead training sessions for Operations staff
- Work closely with Operations team to support related investigations
- Help support investigations and determine the root cause as required
- Propose Corrective Action Preventative Action (CAPA) to training related deviations
- Support all CAPA related training activities for operations team
- Collect and analyze Operations training metrics and identify potential projects/solutions
- Accept Operations related DRs in order to initiate and lead the investigation and the appropriate parties
How will you get there?
- Bachelor's degree in Science or Applied Science or Diploma in Pharmaceutical Technology
- 3- 5 years of related pharmaceutical experience, preferably in a manufacturing environment
- 1-2 years of experience in training – developing learning materials and delivery
- Experience writing SOPs and Work Instructions
- Strong communication skills, both written and verbal
- Proven ability to coach and develop staff as well as the technical ability to coordinate departmental business activities
- Knowledge of cGMP requirements and pharmaceutical processing regulations
- Strong leadership, team building and organization skills
- Excellent computer skills, including the ability to develop spreadsheets, presentations and reports
- Detail oriented and organized, with a high degree of accuracy and thoroughness
- Excellent interpersonal skills
At Thermo Fisher Scientific, each one of our 70,000 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.
To Apply, please click the following link: https://thermofisher.contacthr.com/73692802
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