Aseptic Production Manager
6 days ago
Pharmaceutics International Inc is seeking an experienced Aseptic Production Manager to lead its operations in the formulation and filling of regulated products. The ideal candidate will have a strong background in cGMP, regulatory compliance, and team management.
About the RoleWe are looking for a highly skilled and motivated individual to oversee daily Aseptic Manufacturing operations across assigned shifts. The successful candidate will work closely with various departments, including Operations, Quality Assurance, Technical Services, Validation, QC, Business, and Finance teams.
Responsibilities:- Lead and manage Aseptic Manufacturing Associates, providing guidance, coaching, and mentoring to ensure high-quality output and efficient operations.
- Ensure effective oversight of daily Aseptic Manufacturing operations, scheduling, raw materials management, and maintenance of equipment.
- Serve as a working manager on weekends, as needed, and support other shifts when required.
- Participate in internal and external client meetings, contributing to project discussions and audits.
- Assist in authoring and implementing manufacturing procedures and batch records, ensuring compliance with regulatory requirements.
- Bachelor's degree in Life Sciences or a related field, or equivalent experience.
- A minimum of 4-6 years of related work experience, or a combination of education and experience that provides the necessary knowledge and skills.
- At least 2 years of prior management/leadership experience required.
- Minimum of 4 years Aseptic Production experience, with prior experience interacting with regulatory authorities preferred.
- A thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards is essential.
- Ability to travel between facilities as needed.
- Ability to sit, stand, climb stairs, and use personal protective equipment (PPE) when necessary.
Depending on qualifications and experience, this role offers a competitive salary package with benefits, making it an attractive opportunity for those seeking a challenging and rewarding career in pharmaceutical production.
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