Perform validation activities for IT systems related to company initiatives…Pyramid Consulting Group has a Pittsburgh client with an immediate need for an experienced CSV SPECIALIST to ensure that Commercial Off-The-Shelf (COTS), COTS with configurations and in-house developed software/systems validation are complete and in an auditable state.
Responsibilities include: * Responsible for authoring and execution of IQ, OQ, PQ and Summary Reports; * Responsible for developing Requirement Trace Matrix for the validated system; * Develops, authors, and completes quality system documentation as necessary; * Develops Standard Operating Procedures (SOPs) for the performance of computer system validation; * Initiates Validation Change Requests for various validation changes to the existing system or new system implementation; * Understand and comply with industry standards including International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and United States Pharmacopeia (USP); * Initiate, coordinate and execute projects to ensure the successful completion of CSV.
The client is looking for the following background and skills: * Bachelor's degree in the Life Sciences, Engineering or Computer Science with direct applicable experience in computer software validation is required; * Must possess excellent organizational skills and the ability follow complex processes, procedures and systems; * Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager; * Proficiency in MS Office and other general office equipment; * Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing is preferred,
Pyramid Consulting Group is a recognized leader in today's Information Technology staffing industry. Founded in 1996, Pyramid Consulting Group, Inc. is a professional firm specializing in I.T. Consulting and permanent placement services in the greater Pittsburgh area.
The Pittsburgh Technology Council and The Pittsburgh Business Times have recognized Pyramid's accomplishments by honoring us as one of the Top Fastest Growing Businesses and "Top 50" for many years.
Regardless of the position, Pyramid presents clients with the highest quality of candidates. We conduct business with clients and candidates personally and professionally, building strong relationships with both.
Pyramid Consulting Group, Inc. is an equal opportunity employer and does not discriminate based upon sex, race, religion, marital status or national origin when making a decision to hire an individual.
2800 Corporate Dr Ste 101
Wexford, PA 15090-7604, US