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Compliance Specialist

Posted 20 days ago

  • Expiry Date: 08 October 2022
  • Referral: 215883@accuick.com

Job Description:

  • 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 peeralevel 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 Competencies- Knowledge, skills, and abilities:

  • 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 investigation.

Education and Experience:

  • BS in Engineering or Science related discipline w/minimum 8 years’ experience OR MS w/6 years’ experience in GMP environment/regulated industry

  • 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.

Duties and Responsibilities:
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.

  • Track HPR recommendations and remediation actions.

Ensure ECQ Departmental Compliance:

  • 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.

Compliance Projects:

  • 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.

Ensure Equipment 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.

Regulatory Responsibilities:

  • Assist in the preparation for both internal and external audits.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613