Description
Job Summary:
Responsible for ensuring regulatory compliance through validation and qualification activities for processes, facilities, and equipment; drafting protocols and reports; and supporting supplier management.
Key Responsibilities:
1. Carry out all validation and qualification activities.
2. Support the supervisor in supplier management.
3. Handle national and international standards and guidelines.
**Job Objective:** Carry out all relevant validation and qualification activities to ensure compliance with applicable regulatory requirements and internal procedures for processes, facilities, equipment, and Dankel Medical’s processes.
**Education Requirement:** Bachelor’s degree in Pharmacy and Biochemistry (QFB), Industrial Chemistry (IQ), Industrial Engineering (II), Industrial Technology and Production (ITP), Biotechnology, or related field.
**Core Job Responsibilities:**
* Carry out all validation and qualification activities.
* Stay updated on the plant’s overall operational activities.
* Qualify critical systems, personnel, equipment, and suppliers.
* Validate processes.
* Draft protocols and reports.
* Perform non-viable particle counts.
* Support the department supervisor in managing suppliers providing validation and/or qualification services to the company.
**Minimum Required Experience Areas:**
* Proficiency in analytical techniques.
* Proficiency in technical documentation management.
* Familiarity with national and international standards.
* Familiarity with national and international guidelines.
* Basic proficiency in Microsoft Office.
* Proficiency in Minitab.
* Familiarity with national and international pharmacopoeias and supplements.
***Working Hours:***
Monday to Friday \- 3 rotating shifts
Employment Type: Full-time, Indefinite-term contract
Salary: Starting at $12,500\.00 per month
Benefits:
* Salary increases
* Company parking
* Option for indefinite-term contract
* Cafeteria service
* Discounted cafeteria service
* Grocery vouchers
Work Location: On-site employment