Manager - Validation, Manufacturing Science and Technology
Job Summary
Vacancy: --
Salary: --
Age: Na
Experience: At least 12 years
Location: Gazipur
Published: July 27, 2025
Requirements
Education
- Master of Pharmacy (M.Pharm)
- Master of Science (MSc) in Chemistry
- Master of Science (MSc) in Biochemistry
Experience
- At least 12 years
Additional Requirements
Strong decision-making skill and proven capability to lead validation team;
Excellent interpersonal skill to deal with internal & external stakeholders;
Proficient in utilizing data analytics and KPI insights to optimize manufacturing processes, ensure seamless technology transfers, resolve process issues and maintain regulatory compliance.
Responsibilities & Context
Plan and execute process validation activities in alignment with cGMP and current regulatory guidelines;
Develop validation protocols for process improvement, product launches, scale-up and technology transfers;
Act as Subject Matter Expert (SME) during inspections by authorities such as USFDA, EU, ANVISA, etc;
Conduct cleaning validation, including risk assessments and report generation;
Manage packaging validation through worst-case matrix analysis and documentation;
Lead/support investigations related to deviations, OOS, stability issues and market complaints;
Participate in change control processes and support technical documentation for regulatory submissions;
Collaborate with cross-functional teams to drive best practices and continuous improvement.
Workplace
Work at office
Employment Status
Full Time
Gender
OTHER
Job Location
Gazipur
Company Information
DBL Pharmaceuticals Ltd.