Description:This role is responsible for performing a variety of tasks related to the manufacturing of injectable pharmaceutical products within a regulated sterile manufacturing environment at a senior executive level. The position operates and monitors injectable manufacturing equipment and related apparatus to support parenteral product production objectives with greater independence and accountability. It involves the careful handling of raw materials as well as intermediate and finished injectable pharmaceutical products to maintain product integrity, sterility, and quality. The role contributes to the execution and oversight of injectable manufacturing operations including compounding, filling, and related processes in accordance with established formulations and batch manufacturing records. General maintenance activities on injectable manufacturing equipment and related machinery are performed as required to ensure operational continuity. All activities are executed in strict adherence to Standard Operating Procedures and current Good Manufacturing Practices to meet regulatory requirements. Accurate and timely completion of batch records and manufacturing documentation is maintained as a core accountability. The position participates in and may lead process improvement initiatives aimed at enhancing quality, reducing costs, and optimizing production scheduling within the injectable manufacturing function.
Essential Functions:- Operate and monitor injectable manufacturing equipment and related apparatus with greater independence in accordance with validated procedures and GMP standards.
- Handle raw materials, intermediate products, and finished injectable goods with care to maintain product quality, sterility, and prevent contamination.
- Perform and oversee injectable manufacturing operations including compounding, filling, and related processes per approved batch manufacturing records.
- Mix and compound ingredients for injectable formulations, suspensions, and sterile products per approved procedures.
- Conduct general maintenance on injectable manufacturing equipment and related apparatus to ensure operational readiness.
- Execute Standard Operating Procedures and maintain accurate batch documentation records in compliance with cGMP requirements.
- Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines.
- Lead or participate in functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling.
- Support area cleaning and sanitization activities and mentor junior team members to maintain a compliant and sterile injectable manufacturing environment.
Additional Responsibilities:
Education:
- B. Pharm B. Pharm - Required
- Master Degree (MS/MA) M. Sc. - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Skills Required:
- GMP Compliance & Documentation -Accurate and detailed record-keeping of every step in the injectable Lyphophilizer process. | Expert Level |
- Filling, stoppering and sealing - Understanding of Operation of glass vial/bottle filling and stoppering machine | Expert Level |
- CIP & SIP - Understanding of Operating skill for CIP/SIP skids | Proficient Level |
- Dispensing - Handling & dispensing procedure for different type of materials | Proficient Level |
- Sterilization through Autoclave - | Proficient Level |
- Mixing - Operation of mixing vessels | Proficient Level |
- De-cartoning - Technique for Loading of glass vial / bottle | Expert Level |
- Washing - Operation of glass vial/bottle washing machines | Proficient Level |
- Terminal Sterilization - | Proficient Level |
- Good Manufacturing Practice (GMP) | Proficient Level |
- Batch Record & Document Review | Proficient Level |
- Cleaning & Line Clearance | Basic Level |
- Manufacturing Activity Supervision | | Basic Level |
