ManagerSr. ManagerAGM SME Sterile Manufacturing
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Client: Leading Pharmaceutical Company
Location: Multiple Sites (with 40-50% travel)
Role Overview
The Subject Matter Expert (SME) – Sterile Manufacturing is responsible for managing and supporting sterile manufacturing operations for liquid injectable products including media complex injectables and suspension formulations. The role involves hands-on operation and technical oversight of manufacturing filtration CIP/SIP and isolator-based equipment along with execution of filter integrity testing including 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 manufacturing area.
- To handle process like manufacturing of liquid product including media complex injectable and suspension manufacturing.
- To handle the process equipment in manufacturing like manufacturing skid filtration skid suspension manufacturing skid CIP SIP skid for manufacturing and filtration equipment’s dispensing isolators manufacturing isolators pH meter DO meter integrity tester etc.
- Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.
- Handling and recording of procedure like line clearance area cleaning and sanitization batch manufacturing and filtration etc.
- Experience for preparation and execution of qualification protocol of new equipment like User requirement specification Design qualification Installation qualification operational qualification and performance qualification.
- To prepare of new standard operating procedure for process and equipment’s.
- Experience for preparation of batch manufacturing records.
- To handle the QMS documents like change control CAPA risk assessment deviation etc.
- To handle communication with vendor and procurement team on procurement to design parts of new equipment’s.
- To ensure compliance to cGMP and documentation for various production activities.
- Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.
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.
- 15 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
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
