Manager Senior Manager AGM SME Filling
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Client: Leading Pharmaceutical Company
Location: Multiple Sites (with 40-50% travel)
Role Overview
The SME – Filling will be responsible for overseeing and executing aseptic filling and lyophilization operations in the sterile production area. The role requires strong technical expertise in aseptic processes equipment operation troubleshooting and compliance with cGMP and regulatory role requires extensive travel (40-50%) to support multiple facilities audits and technology transfers.
Key Responsibilities
- Expertise in operation of below process and equipment’s:
- To handle aseptic and lyophilisation area.
- To handle process like filtration filling Lyophilizer loading and unloading lyophilisation process and capping.
- To handle the process equipment’s and its trouble shooting like filling machine capping machine Lyophilizer loading and unloading system Lyophilizer filtration skid and isolators VHP pass box mobile LAF etc.
- Exposure to perform the Smoke study of entire filling line and process like filtration filling assembly filling operation aseptic intervention during filling loading and unloading smoke study in static and dynamic conditions.
- Knowledge about aseptic practices aseptic behaviours media fill simulation aseptic gowning and de-gowning process aseptic area cleaning and sanitization process personal gowning qualification.
- To handle preparation and execution of qualification protocol of new equipment area cleaning and sanitization etc.
- Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.
- Exposure for User requirement specification Design qualification Installation qualification operational qualification and performance qualification.
- Experience for preparation of batch manufacturing records.
- To handle the QMS documents like change control CAPA risk assessment deviation etc.
Common Responsibilities
- Travel (40-50%) to our facilities for audits training troubleshooting and technology transfer.
- Collaborate with R&D QA and Engineering teams to ensure process excellence.
- Author and review technical documentation validation protocols and reports.
- Ensure compliance with global regulatory standards (FDA EMA WHO).
- Mentor and train operators and technical staff.
Qualifications
- Bachelor’s/Master’s in Pharmacy Biotechnology or related discipline.
- 10 years of hands-on experience in the respective domain - sterile Manufacturing.
- Proven expertise working with different makes/models of equipment or directly with OEMs.
- Strong knowledge of cGMP regulatory requirements and validation practices.
- Excellent communication analytical and cross-functional collaboration skills.
- Willingness to travel up to 40-50% of the time.
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
