Job Description:
With direct supervision, the candidate is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principles, quality policies, standards, and core values. Maintains the company's right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.
Technical Responsibilities:- Perform qualification of laboratory equipment in accordance with EQ policies, plans, and procedures.
- Coordinate with laboratory personnel to define qualification requirements.
- Author, review, and execute equipment qualification protocols.
- Coordinate equipment qualification activities with vendors and other support groups.
- Identify business, quality, and compliance gaps.
- Sign documents for activities as authorized and described by Genentech policies, procedures, and job descriptions.
- Perform any other tasks as requested by Senior Management to support QC laboratory operations.
Requirements :
- BS/BA degree (preferably in a relevant scientific discipline).
- Experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience.
- Knowledge of cGMP or equivalent regulations.
- Minimum of two years' experience in Validation or equipment qualification is desired.
- Ability to make sound decisions about scheduling and managing priorities.
- Flexibility in problem-solving, providing direction, and work hours to meet business objectives.
Knowledge / Skills / Competencies:
- Possesses strong verbal and written communication skills and the ability to influence at all levels.
- Capable of building trustful and effective relationships.
- Able to think strategically and translate strategies into actionable plans.
- Takes responsibility, drives results, and achieves expected outcomes.
Work Environment / Physical Demands / Safety Considerations:
- Standard office environment