Manager Sr. ManagerAGM- SME (granulation Compression )
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Job Location:
Maharashtra - India
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Client: Leading Pharmaceutical Company
Location: Multiple Sites (with 50% travel)
Role Overview
We are seeking highly experienced Subject Matter Experts (SMEs) across key manufacturing domains: Compression Granulation Operations. Each SME will be responsible for providing deep technical expertise process optimization and compliance oversight in their respective area. The role requires extensive travel (50%) to support multiple facilities audits and technology transfers.
Key Responsibilities (per area)
SME – Compression
- Lead process design scale-up and troubleshooting for tablet compression.
- Provide expertise on different makes/models of compression equipment including OEM systems.
- Develop SOPs batch records and validation protocols.
- Train operators and ensure compliance with cGMP and regulatory standards.
SME – Granulation
- Oversee wet and dry granulation processes ensuring robust scale-up and reproducibility.
- Optimize granulation parameters across different equipment models.
- Support technology transfer and harmonization across sites.
- Conduct training and audits to ensure compliance.
Common Responsibilities
- Travel (50%) to our facilities for audits training troubleshooting and technology transfer.
- Collaborate with R&D QA and manufacturing 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 Chemical/Mechanical Engineering or related discipline.
- 8–12 years of hands-on experience in the respective domain (Compression Granulation ).
- 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 50% of the time.
Required Skills:
Engineering Projects Compression Granulation
Key Skills
- Restaurant Experience
- Customer Service
- Employee Evaluation
- Management Experience
- Math
- Employment & Labor Law
- Sanitation
- Leadership Experience
- P&L Management
- Mentoring
- Supervising Experience
- Restaurant Management
