Responsibilities
- Responsible for managing shift or multiple shift operations within manufacturing departments.
- Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing decisions.
- Interprets manufacturing policies, procedures, and programs.
- Supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes.
- Validation activities include research, protocol writing/execution and final report generation.
- Conducts investigations of manufacturing challenges and process improvements evaluation/implementation.
- Final documents are archived and may be included in or support A/NDA submissions and made available as needed during FDA, MHRA, and client/customer compliance audits.
Requirements
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, computer software.
- Direct industry knowledge.
- Ability to work independently or in teams.
- Ability to walk some distance 1 to 3 miles, stand for 3 to 6 hours and lift 10 to 40 lbs. during the course of a work day as required.
- Ability to work any shift (1st, 2nd or 3rd) on any day of the week (7 days) as duties require.
- Ability to become clean room gown trained/qualified and to work within the sterile suite areas for up to a full 8-hour shift (with appropriate breaks).
Core Competencies
Demonstrates expertise in managing manufacturing operations, ensuring compliance with FDA and MHRA standards, and conducting validation activities for pharmaceutical processes. Proficient in technical writing and effective communication across all levels, with a strong focus on quality and production goals.
Certifications & Qualifications
- Clean Room Gown Training
Tools & Technologies
- Microsoft Word
- Microsoft Excel