Job Description:

We are currently seeking a skilled and experienced External Approved Chemist/Manager with FDA approval in the external section. The ideal candidate should have a comprehensive understanding of the manufacturing, filling, and packing processes specifically related to cream, ointment, lotion, and gel formulations.

Job Responsibilities:

1. FDA Compliance: Ensure strict adherence to FDA regulations in the external section, overseeing all activities related to compliance with regulatory standards.

2. Formulation Knowledge: Demonstrate expertise in the manufacturing, filling, and packing processes of cream, ointment, lotion, and gel products.

3. Documentation: Prepare and maintain crucial documents such as Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Log books, and other relevant documentation.

4. Quality Control: Implement and monitor quality control measures throughout the manufacturing and packing processes, ensuring products meet the highest standards of quality and safety.

5. Process Optimization: Collaborate with internal teams to optimize manufacturing processes, improving efficiency and minimizing waste.

6. Team Leadership: Lead and manage a team of professionals, providing guidance and support to ensure seamless operations in the external section.

Qualifications and Skills:

1. FDA approval in the external section is mandatory.
2. Minimum of 6 years of experience in the manufacturing, filling, and packing of cream, ointment, lotion, and gel products.
3. Proficient in document preparation, including SOPs, BMRs, BPRs, and Log books.
4. Strong knowledge of regulatory requirements in the pharmaceutical industry.
5. Excellent organizational and leadership skills.
6. Detail-oriented with a focus on quality and compliance.