Team Leader - Sterile

Title: Team Leader – Sterile

Job Summary and Responsibilities

1. Processing: Dispense raw materials, formulation, material preparation, filtration, filling, inspection, labeling, and shipment in strict adherence to GMP principles.
2. Process Documentation: Prepare, review, and approve process-related documentation such as Batch Manufacturing Records (BMR), Standard Operating Procedures (SOPs), and logbooks.
3. Machine Operations: Assemble machine parts in the cartridge filling line and manage cartridge filling operations during the media fill and batch production processes within Class-B areas.
4. Material Management: Monitor and check production materials such as raw materials, PPM, and SPM, and plan accordingly for production requirements.
5. Cross-Functional Teamwork: Collaborate with cross-functional teams to ensure critical project tasks are completed effectively.
6. SOP Training and Revision: Prepare, revise, and provide training on all required SOPs within the department.
7. Batch Record Review: Review processed batch records prior to product release to ensure quality standards are met.
8. Process Validation: Oversee process validation, optimization, and scale-up activities to ensure quality and efficiency.
9. Cleaning Schedules: Coordinate area cleaning schedules and ensure proper disinfectants are used for cleaning.
10. Cleanroom Maintenance: Maintain the cleanliness and compliance of Class-A & Class-B cleanroom areas.
11. Aseptic Training: Provide proper training for aseptic operators, ensuring adherence to cleanroom behaviors.
12. Maintenance Support: Initiate and follow up on breakdown maintenance work orders and preventive maintenance procedures.
13. Employee Training: Provide ongoing job role training for employees to ensure operational excellence.
14. Support CIP & SIP: Assist with CIP (Clean-in-Place) and SIP (Sterilization-in-Place) programs as required.
15. Problem Resolution: Investigate and troubleshoot issues, recommending solutions or improvements to enhance operational performance.
16. EDMS and eQMS Tools: Handle EDMS and eQMS tools like Change Control, Deviations, Exception Management, CAPA, etc.
17. SOP Development: Write, review, and propose new or updated SOPs to improve the Quality Management System (QMS) and related processes.
18. Assistance in Unit Operations: Assist in other unit operations and activities as required or instructed by the Manager or Department Head.

Qualifications and Functional Knowledge

1. Strong communication skills with the ability to collaborate effectively within a team and across functional areas.
2. Quick learner with the ability to adapt to new processes and systems efficiently.
3. Accountable, committed, and results-oriented with a focus on meeting deadlines.
4. Proficient in reading and understanding SOPs and BMRs to ensure compliance.
5. Bachelor’s degree in Pharmacy or Pharmaceutical Chemistry.
6. Advanced knowledge of cGMP (current Good Manufacturing Practices) principles and production processes.

We value people from different backgrounds.