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Job Description
Job Summary: Provide compliance support for SCM/Warehouse/Weigh and Dispense operations to ensure processes and end products comply with corporate and regulatory requirements.
This is an 11-month initial contract. The purpose is to provide compliance support for SCM/Warehouse/Weigh and Dispense operations to ensure processes and end products comply with corporate and regulatory requirements.
Responsibilities:
- Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP.
- Drive compliance with Global policies, procedures and guidelines and regulatory requirements.
- Execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Provide support for the SCM/Warehouse/Weigh and Dispense with respect to the following:
- Updating of Standard Operating Procedures, Shipping & Receipt Documents, protocols and associated reports.
- Review of eLogs and archiving/retrieval of SCM/Warehouse/Weigh and Dispense documentation.
- Maintaining and controlling the SCM/Warehouse/Weigh and Dispense documentation areas.
- Act as compliance point of contact for all SCM/Warehouse/Weigh and Dispense documentation topics.
- Assist in the review of SCM/Warehouse/Weigh and Dispense operational procedures, training materials and procedures for various systems.
- Support documentation in support of investigations, non-conformances, protocols, reports and change controls.
- Assist in the review of data for periodic reviews as required.
- Drive continuous improvement for all aspects of documentation control/ archival.
- Contribute to the achievements of department productivity and quality goals.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Liaise with site QA Document Control group.
- Participate in internal and external audits and inspections.
- Participate in SCM/Warehouse/Weigh and Dispense Tier daily meetings and ensure effective communication of relevant information.
- Completion of Projects in an efficient and timely manner as agreed with the area manager.
Requirements:
- 3-5 years experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment.
- Bachelors Degree with 3+ years experience in Pharma and Compliance or Leaving Cert with years experience in Pharma and Compliance.
- Skills: Compliance Support Documentation Quality GMP 3 Plus Years Experience in Quality.