Validation & Compliance Specialist

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Company: Katalyst HealthCares and Life Sciences

Location: Summit, NJ 07901

Description:

Responsibilities:
  • 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.
  • Track HPR recommendations and remediation actions.
  • Participate in revisions to departmental procedures to ensure compliance.
  • Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines.
  • Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance.
  • Lead projects both small and large in scope required to keep equipment or the department in compliance.
  • Receive and review revisions to USP, EP, JP, FDA regulatory guidelines.
  • Provide guidance to the team if changes are required.
  • Perform gap analysis on existing equipment and technologies to ensure compliance.
  • Review new equipment and technologies as it comes to site to ensure compliance.
  • Assist in the preparation for both internal and external audits.
Requirements:
  • Required BS in Engineering or Science related discipline w/minimum 4 years' experience.
  • MS w/2 years' experience in GMP environment/regulated industry.
  • 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 multi-tasking 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 investigation.
  • 5-7 years' experience in a pharmacopeia compliance related discipline preferred.
  • 5-7 years' 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.
Physical Demand:
  • Occasional stooping, bending, stretching, pushing, pulling, reaching the candidate should be able to lift 25 pounds with assistance.
  • Ability to sit, stand, walk and move within workspace for extended periods.
  • Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
  • The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multi-use 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.

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