Manager - Validation, Manufacturing Science and Technology

Job Description

Title: Manager - Validation, Manufacturing Science and Technology

Company Name: DBL Pharmaceuticals Ltd.

Vacancy: --

Age: Na

Job Location: Gazipur

Salary: --

Experience:

• At least 12 years

• Master of Pharmacy (M.Pharm)
• Master of Science (MSc) in Chemistry
• Master of Science (MSc) in Biochemistry

• At least 12 years

• 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.

• 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.