Vacancy expired!
Our client, a leading pharmaceutical company is hiring a COMPLIANCE SPECIALIST on a contract basis.
Work Location: Summit, NJ Summary Purpose and Scope of the Position The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multiuse sites through interaction with internal team members and peer level customers as well as external service providers. The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines. The incumbent will perform periodic reviews of equipment, policies and procedures, gap analysis where required, and small-scale projects to complete departmental objectives.Required Skills • Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. • Strong attention to detail. • Strong written and verbal communication skills. • Excellent interpersonal skills with experience dealing with a diverse workforce. • Strong multitasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. • Strong presentation development and delivery skills. • Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business. • Ability to organize and present data and findings clearly. • Possess experience with investigationCompetencies: • Professional Knowledge • Action and detail oriented • Team Player / Building Relationships • Multitasking • Customer Focus • Problem Solving • Active ListeningEducation and Experience: • BS in Engineering or Science related discipline. • Minimum 5 years experience in GMP environment / regulated industry. • 2-3 years experience in a pharmacopeia compliance related discipline preferred. • 2-3 year' experience with troubleshooting complex laboratory equipment. • Working knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP. • Excellent computer skills including knowledge of equipment data quality systems. • Strong verbal and written communication skills, and the ability to work independently. • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.Duties and Responsibilities 1) Historical Performance Review: • Execute the historical performance review (HPR), a periodic review of equipment performance and use. • Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend. • Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines. • Identify and recommend actions to take because of HPR findings. • Write deviation and perform investigation per internal procedure.- Apply Now
Vacancy expired!