6 month contract to start in September with option to extend.
Perform QA support and oversight for equipment, automation and IS validation. This function does NOT develop the technical solutions.
The QA validation specialist will work under supervision of qualified Amgen staff. Level of independency will vary based on familiarity with the subject (e.g. equipment, automation, etc).
Expectation is that staff can perform selected QA validation activities within one month from starting date.
Position Specific Tasks
Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
Keeps quality oversight on validation strategy and deliverables for specific projects.
Maintain a close contact and familiarity with Amgen Quality systems.
Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
Education and Experience:
Master Degree in Engineering, Pharmaceutical sciences, Process Technology, or equivalent.
10 years of professional experience in GMP environment.
5 years relevant experience in Equipment and Automation Validation, preferably related to secondary packaging.
Additional experience with Non Conformances, CAPA’s and Change Control
Skills and Knowledge:
Expanding knowledge of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
Good attention to detail and excellent writing skills in English language.
Effective communication skills at multiple levels and areas (inside and outside of Quality).
Good decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.
Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
Works under minimal direction.
Work is guided by operational and project objectives.
Manages multiple assignments and processes.
Independently determines approach to project.