What are the responsibilities and job description for the Deviation Investigator - Pharma position at TekOne IT Services Pvt. Ltd.?
Role: Deviation Investigator - Pharma
Location: Baltimore, MD
#On-Site
Key Responsibilities
Location: Baltimore, MD
#On-Site
Key Responsibilities
- Review project and system deliverables, including Master Batch Records, plans, specifications, and change controls.
- Ensure adequacy of system operational and administration procedures.
- Document non-compliance findings and assist with remediation strategies.
- Document and review remediation activities.
- Perform additional duties as assigned.
- BS in Chemical, Biomedical, or Biochemical Engineering, Biological Sciences, or related field/experience.
- Min. 2 years of industry experience in a cGMP environment.
- Knowledge of cGMP manufacturing and regulatory requirements for biotech, pharmaceuticals, and medical devices.
- Experience in quality assurance, reviewing Master Batch Records, and validation documents.
- Proficient in documenting remediation activities.
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