Showing posts with label Scientist. Show all posts
Showing posts with label Scientist. Show all posts

Validation Scientist


Details: Title:                   Validation Scientist III,Duration:           11 + months (initially) with possible extensionLocation:          Los Angeles, CA Job Description: The TA Validation Senior Scientist will be responsible for the process validation of new and currently marketed cosmetic, personal care and OTC Monograph drug products under our Client Beauty Franchise. This individual must have knowledge of the principles and approaches of product related process validation and will be responsible for providing hands on technical support to the Validation Manager in the design, development, and the implementation of validation studies meeting FDA requirements for products manufactured within the Client Los Angeles production facility. The validation program scope includes Semisolid (creams, gel and lotions) and Liquid products including OTC Monograph products. This individual will be accountable to the Validation Manager and responsible for assisting in the execution and maintenance of the Los Angeles facility process validation program and Validation Master Plan. The TA Validation Senior Scientist will provide hands on support and technical project management in the execution and maintenance of the validation program, including: study/protocol design, documentation, validation execution and process/cleaning revalidation activities. This individual is expected to be a resource within the manufacturing facility as it relates to validation activities and must have the ability to train personnel facility wide on validation requirements during the execution of the validation program. Validation documentation must be completed using good science and at a quality level that meets the established OTC Monograph, FDA, and Client Quality Compliance standards. This individual will work in a team environment with Operations/ Supply Chain, Quality Assurance, Technical Transfer, Analytical Development, Microbiology, Product Development and Regulatory personnel. This position reports into the Validation Manager, Technical Assurance.  Qualifications: A minimum of a Bachelors degree with 6+ years of professional experience or a Masters degree with 4+ years of professional experience, or a PhD with 0-2 years of professional experience is required. A degree in Chemical Engineering/ Industrial Pharmacy or related field of study is preferred. Experience in process validation of OTC Monograph or NDA products within a FDA regulated production facility is required. Knowledge of the principals and approaches to validation and the FDA Validation Guidelines are required. Understanding of cGMP’s and current industry FDA Compliance requirements is required. Some knowledge of the validation of semisolid/liquid products and semisolid/liquid process technology is preferred. The candidate must be able to work independently with some supervision and have excellent oral and written communication skills. The candidate should have the ability to work collaboratively across functional groups in the execution of validation activities. This candidate must be a problem solver; detail oriented, and must be able to handle multiple responsibilities and projects. This candidate is expected to interact with team members, business and research partners across the manufacturing/business enterprise in accomplishing team project goals and objectives. This position may require minimal travel and is located in Los Angeles, California. A degree in Chemical Engineering/Industrial Pharmacy or related field of study is preferred. Experience in process validation of OTC Monograph or NDA products within a FDA regulated production facility is required. Knowledge of the principals and approaches to validation and the FDA Validation Guidelines are required. Understanding of cGMP’s and current industry FDA Compliance requirements is required. Candidate should be willing to do shift work (1st, 2nd and 3rd) and we can reduce years of experience to 3+ Bachelors degree and 2+ with a Masters with 0 required for a Ph.D.

View the original article here

Powered by Blogger.