Aseptic Operations Supervisor
2 weeks ago
Aseptic Operations Supervisor
As a key leader at Germer International, the Aseptic Operations Supervisor is responsible for steering the company’s operations with a focus on Aseptic Manufacturing processes, including formulation and filling. This role collaborates extensively with various departments, including Operations, Quality Assurance, Technical Services, Validation, and Finance.
Key Responsibilities:
- Lead and mentor a diverse team of Aseptic Manufacturing Associates, focusing on recruitment, management, motivation, and professional development.
- Oversee Aseptic Manufacturing operations across multiple shifts, providing weekend support as necessary.
- Conduct thorough internal batch record reviews to ensure compliance and accuracy.
- Assist in the creation and execution of manufacturing procedures and batch records.
- Manage daily manufacturing activities, including scheduling and inventory management of raw materials and consumables.
- Provide guidance during component preparation, bulk drug formulation, and aseptic filling processes.
- Ensure precise documentation of data and completion of batch records as required.
- Successfully complete gowning and media fill qualification programs for facility compliance.
- Train staff in various manufacturing tasks, including Component Preparation, Formulation Operations, and Sterile Filling.
- Operate and maintain production equipment, ensuring optimal performance.
- Maintain cleanroom environments and ensure compliance with cleanliness standards.
- Verify that all personnel on shift are adequately trained on relevant procedures and master batch records.
- Initiate revisions to cGMP procedures and master batch records as necessary.
- Assist in scheduling and conducting routine maintenance and calibration of production equipment.
- Engage in client communications, providing updates on project status and addressing any issues that arise.
- Interface with auditors, including client representatives and regulatory bodies.
- Review and approve cGMP documentation to support continuous improvement initiatives.
- Support audits from agencies, customers, and vendors, maintaining a professional demeanor that reflects positively on the company.
- Perform additional tasks and projects as assigned.
Qualifications:
- Comprehensive understanding of cGMP, FDA guidelines, and international regulatory standards is essential; experience in aseptic manufacturing of regulated products is highly desirable.
- Proven ability to lead a team of cGMP associates in a controlled environment.
- Skilled in identifying and addressing cGMP gaps within a multidisciplinary team.
- Strong understanding of Quality principles and procedures in pharmaceutical, biopharmaceutical, or biotech manufacturing settings.
- Exceptional integrity and professionalism in all interactions.
- Effective communication skills, both written and verbal, with management, staff, and regulatory representatives.
- Proven track record of managing teams to achieve objectives efficiently.
- Strong decision-making skills regarding scheduling, resource allocation, and priority management.
- Proficient in Microsoft Word, Excel, and Outlook.
Join Germer International and contribute to our commitment to excellence in Aseptic Operations.
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