Author manufacturing investigations and complete CAPA assignments.
Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
Interact with clients during routinely scheduled project meetings.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.
Qualifications
Bachelor’s degree in Engineering, Pharmacy, or Chemistry.
5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.
Previous experience supporting tech transfer of parenteral Drug Products preferred.
Knowledge, Skills, and Abilities
Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required.
Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
Working knowledge of EU regulations preferred.
Proficiency with Microsoft office (Word, Excel, Outlook) required.
Ability to interact with internal stakeholders and external customers.
Travel Expectations
Up to 5% domestic travel.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance; and taste or smell. The employee must frequently lift and/or move up to 25 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.
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