Morrisville, NC US
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.
- Title: VALIDATION SPECIALIST
- Location: Morrisville, NC.
- Industry: Pharmaceutical
- Hours: Shift M-F 8am 5:30pm
- Salary: $40-45hr Based on Experience (Paid Weekly - Benefits Available)
- Employment Type: 6 months (Possible Hire)
The Quality Assurance department plays a necessary role in the daily operations of the facility. The primary function of the department is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. The department is entirely separate from and independent of the personnel engaged in the direction and conduct of the project. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material and finished-product release.
This position is responsible for developing, preparing, executing or oversee the execution of, and revising test validation procedures/protocols to ensure that there is sufficient documentation to support the manufacturing of a product in accordance with appropriate regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices. He or she also compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements to the process. He or she may also investigate and troubleshoot problems in the manufacturing and cleaning processes and determine solutions. The position will also provide similar support to the cleaning processes used in manufacturing and the utilities (water system, compressed gas systems and HVAC systems) to support the manufacturing. This position will also present and defend the validation activities during audits by customers and regulatory authorities. The position requires independent performance and the ability to identify validation requirements, manage their time, handle multiple projects simultaneously and analyze and resolve the unique situations presented by clinical manufacturing in the challenging dosage forms intended to be made at the site (sterile, inhalation metered dose inhalers and dry powder inhalers). Comply with divisional and site Environmental Health and Safety requirements.
Essential Job Functions:
- Author or review and approve all factory acceptance tests (FATs), site acceptance tests (SATs), commissioning, User Requirement Specifications, IQ, OQ, and PQ and summary reports, validation protocols associated with laboratory instrumentation and equipment. Execute these protocols if manpower needs dictate it.
- Review and approve risk assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan.
- Review and approve related SOPs.
- Perform computer system validation on specific laboratory equipment such as HPLC s etc.
Must Have Requirements:
- Must have knowledge of current industry expectations of validation requirements for process validation, cleaning validation, computer validation, and equipment qualification.
- Ability to handle multiple projects and deliver on project timelines with little supervision.
- Ability to determine, present, and defend professionally project requirements and status.
- Knowledge of all current cGMP requirements in the US and other parts of the world
- Ability to communicate clearly to all levels (operator to senior management) within the site
- Must be able to utilize Microsoft Office
- Understanding of statistical evaluation tools
- Self-starter who exhibits a professional demeanor, enthusiasm, communications, and the ability to work independently with minimal supervision.
- Sound knowledge and experience of pharmaceutical industry standards and requirements
- Work well in cross-functional departments
Minimum Education and Experience:
- BS in Engineering, Chemistry or other related scientific discipline with a minimum of 5 years' experience with GMP document creation related to CSV.
- The position will be stationed in an office environment
- Flexibility required to work outside normal working hours of 8:00 a.m. 5:00 p.m.
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
- Specific vision requirements including reading of written documents and use of computer monitor screen frequently.