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Form of workJob Description
Biotechnology company is hiring a Quality Technical Manager to ensure the company's Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed.
Responsibilities
- Participate in inspection readiness, regulatory inspection support and self- inspection activities.
- Quality system metrics and trending.
- Works cross functionally with management within and outside Technical Operations to ensure consistency of use of the quality systems.
- Participate in quality system improvement and process mapping initiatives.
- Author and own site Quality Technical Agreements.
Qualifications
- Bachelors or Masters preferably in the life sciences
- 6+ years experience in pharmaceutical or related industry.
- Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.
- Ability to comprehend technical information related to analytical methods, manufacturing processes and regulatory expectations.
- Familiarity with FDA, European and international regulatory requirements.
R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.
The cornerstone of our success: a knowledgeable and experienced recruiting team.
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
The cornerstone of our success: a knowledgeable and experienced recruiting team.
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
