Note: The job is a remote job and is open to candidates in USA. Element Staffing is currently hiring a Technical Investigation Writer for a pharma manufacturing client. This role involves investigating quality deviations and collaborating with various teams to ensure compliance and timely resolution of issues.
Responsibilities
- Investigate the quality deviations observed during raw material dispensing / manufacturing / packaging operations
- Review GMP documents such as SOPs, Batch records, Logbooks to identify the root cause for the reported deviation using Kepner-Tregoe, Ishikawa, Fish bone, 5 Why methods
- Partner with Technical Services, Engineering and Manufacturing team members to determine the scope, impact and risk associated with the deviations/non-conformances observed in Manufacturing and Packaging department
- Work with QA Compliance team members to finalize investigation reports and identify necessary CAPA for the reported deviation/non-conformance in timely manner
- Ensure timely implementation of CAPA resulting from deviations, customer complaints, Internal Audits. Monitor and ensure closure of all open deviations/non-conformances and CAPAs within defined timeframes
- Review deviation trend to determine and propose appropriate actions needed to prevent reoccurrence of similar events
- Review and revise GMP documents (SOPs/Work Instructions/Productions Records, etc.)
Skills
- Experience in investigating quality deviations in pharma manufacturing
- Ability to review GMP documents such as SOPs, Batch records, and Logbooks
- Familiarity with root cause analysis methods including Kepner-Tregoe, Ishikawa, Fish bone, and 5 Why
- Experience partnering with Technical Services, Engineering, and Manufacturing teams
- Ability to work with QA Compliance team to finalize investigation reports
- Experience in identifying necessary CAPA for reported deviations/non-conformances
- Ability to ensure timely implementation of CAPA resulting from deviations, customer complaints, and Internal Audits
- Experience in monitoring and ensuring closure of all open deviations/non-conformances and CAPAs
- Ability to review deviation trends and propose actions to prevent reoccurrence
- Experience in reviewing and revising GMP documents (SOPs/Work Instructions/Production Records)
Benefits
- Remote work option
- 3-4 month contract opportunity
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