Job Description
We are currently recruiting for an exciting opportunity with a leading multinational pharmaceutical organization.
Duties
* Expertise in document systems, including review, approval, and workflow expedition. Format, write, deliver, and review necessary documentation according to standard approval processes, and facilitate others to do so. Documents include SOPs, SWIs, training documents, and change controls.
* Support operations through documentation generation, filing, tracking, auditing, and efficient maintenance of associated databases, including process documentation system maintenance, auditing, and archiving.
* Timely Quality Notification completion, interim/summary report generation, and meeting batch release requirements to support batch release.
* Raise CAPAs and conduct investigations using standard tools and methods to resolve system issues, implement corrective action through the change management system, and ensure quality notifications are closed out in conjunction with the SCM team.
* Investigate customer complaints and Change Controls to support production activities in a timely manner.
* Comply with Merck Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in day-to-day activities and job functions.
Education & Experience
* Bachelor's Degree or higher preferred in Science, Engineering, or other Technical discipline.
* SAP knowledge and experience required.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile filling processes and equipment.
* Lean Six Sigma Methodology experience desired.