Job Description
Job Description
The Technical Manager will oversee the stability testing program, ensuring compliance with GMP and regulatory requirements. This role involves managing analytical testing review, addressing out-of-specification (OOS) results, and reviewing lab testing and product development reports. The ideal candidate will have extensive experience in the pharmaceutical or food industry, with a strong understanding of good laboratory practices (GLP).
Key Responsibilities :
- Lead and manage the stability testing program, ensuring compliance with GMP and regulatory standards.
- Review and interpret analytical testing results, addressing any OOS findings.
- Manage outside laboratory testing and ensure accurate and timely reporting.
- Evaluate the reactivity of plastic components based on their type and ensure compatibility with products.
- Collaborate with cross-functional teams to support product development and stability testing.
- Maintain detailed documentation and ensure all records are compliant with regulatory requirements.
- Provide technical expertise and guidance on stability testing and analytical methods.
- Audit outside laboratories.
- Stay updated on industry trends and regulatory changes to ensure ongoing compliance.
Qualifications :
Minimum of 7 years of experience in the pharmaceutical or food industry.Strong background in GMP, GLP, and regulatory compliance.Proven experience in analytical testing and handling OOS results.In-depth knowledge of plastic components and their reactivity.Excellent analytical and problem-solving skills.Strong communication and interpersonal skills.Ability to work independently and as part of a team.Proficient in Microsoft Excel.Bachelor's degree in Analytical Chemistry, Pharmaceutical Chemistry, or a related fieldWe offer Medical, Dental, paid time off, paid holidays and more!
For more information, please call Melissa @ 815-997-1442
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