For approximately 6 months
Responsible for generating and/or reviewing documentation required to commission and qualify (C&Q) manufacturing equipment, utilities and facilities associated with processes. Write lists of spare parts for equipment to be activated, as well as maintenance plans for equipment and utilities associated with processes. Develops and/or reviews, as applicable, operational procedures (SOPs) for the operation and maintenance of equipment, utilities and engineering systems that apply. Organizes the required documentation for each team or area. Ensures that the required information is entered into the SAP system. Manages document approval. Document the completion of deliverables. Interface with cross-functional teams on special projects or on an as-needed basis. Perform general clerical work such as filing, copying, mailing, etc.
1. Works with limited supervision and has a flexible approach to work assignments
2. Maintaining and monitoring documentation status.
3. Organizing, attending, and participating in meetings.
4. Manages workload priorities and keeps supervision informed of challenges and availability
5. Establish and maintain effective working relationships with those contacted while performing assigned work.
6. Manage department documentation by generating reports as needed (weekly, monthly, quarterly, and annual) of orders generated in the system. Classify them by corrective/preventive/calibration. Reconcile the orders printed and handed to the compliance unit for archive. Revise that all documents comply with current Good Manufacturing Practices (cGMP’s) documentation prior to archive them.
7. Support the equipment life cycle by assigning Installation Qualification (IQ)/operational qualification (OQ)/ Performance Qualification (PQ) protocol numbers. Maintain in compliance the logbook assuring that all numbers assigned are either completed and/or cancelled. Store all capital projects documentation and assure it complies with its record retention period. Provide all documentation packages during decommissioning process.
8. Assist when required that all Stand Operating Procedures (SOP’s)/ Forms and guidelines be within their effective dates and assist on the document revision workflow.
9. Assist in generation and review of documentation that supports qualifications, such as maintenance plans (ARPM), spare parts lists, SOPs, etc. Ensures that all Standard Operating Procedures (SOP’s)/ Forms and guidelines are within their effective dates and assist on the document revision workflow.
10. Enters required data to SAP (maintenance plans, spare parts lists, etc.).
11. Organizes and files documentation.
12. Comply with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and internal notifications of any environmental event.
13. Perform other duties as assigned
EDUCATION AND/OR EXPERIENCE
• Bachelor’s Degree in Secretarial Science, Administrative Management or related field is preferred.
• Three (3) years of increasingly responsible clerical experience preferably with two years of experience working with pharmaceutical industry compliance documentation.
• Bilingual- written and oral communication
• Competency in Microsoft applications including Word, Excel, and Outlook
• SAP knowledge required