Assistant Manager - Development Quality Assurance

Job Description

Title: Assistant Manager - Development Quality Assurance

Company Name: DBL Pharmaceuticals Ltd.

Vacancy: --

Age: Na

Job Location: Gazipur

Salary: --

Experience:

• At least 8 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Master of Pharmacy (M.Pharm)

• At least 8 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Advanced knowledge in MS Suite.

• Strong decision-making skill with the ability to work independently and collaboratively.

• Strong interpersonal skill to deal with internal & external stakeholders.

• Monitor and review experiments and development batches for adherence to internal quality standards.

• Review and approve various R&D documents such as analytical method validation protocols and reports, product development report, SOPs etc.

• Review and support investigations into deviations, out-of-specification (OOS), and out-of-trend (OOT) results during development.

• Evaluate and approve change controls related to R&D activities.

• Participate in risk assessment related to process or method development.

• Conduct internal audits of R&D labs to ensure compliance with regulatory standards

• Support external audits by regulatory bodies or clients by providing necessary documentation and clarifications.

• Ensure that R&D staff are trained on applicable SOPs, GLP/GMP, and quality standards;

• Monitor for data integrity issues in lab notebooks.

• Ensure compliance with ALCOA++ principles.