Senior QA Auditor

Are you passionate about improving the quality of human life? If so, we invite you to join us in building a healthier world tomorrow!

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & and currently employing 14,000 people across 97 offices in 38 countries.

Description

ICON is looking for a Sr QA Auditor to work with the CAPA team on quality issue and CAPA management

This is a fantastic opportunity to join the elite audit team focused on making an impact globally and supporting ICON’s mission – to help its clients accelerate the development of drugs and medical devices that save patient lives and improve their quality of life.

Job Responsibilities

As a Sr QA Auditor the role would involve

• Predominantly Working with the CAPA team on quality issue and CAPA management
• This is a dual role working with both the CAPA team and audit defence team.
• There is an expectation that the auditor will also host sponsor audits, alongside the APAC CQA team, in the Bangalore and/or Chennai offices as needed.
• Other responsibilities include supporting site inspection preparation activities, leading inspection readiness teams, and supporting inspections of ICON.

AUDIT DEFENSE Responsibilities

• Lead Sponsor Audits and/or Regulatory Inspections of ICON activities including
• Preparation activities including liaising with the client, identifying, escalating and mitigating any risks and preparing operational teams
• Host Sponsor on-site or remote audits including leading opening and close out meeting activities, supporting operational targets in audit defense activities, calling out potential issues as needed, and providing audit summaries to senior management.
• For regulatory inspections of ICON, lead / assist with the leadership of the on-site inspection activities: lead document request activities and/or act as ’back room’ leader, lead inspection room activities on behalf of the Q&C Manager / Director, when needed, including direct communication with the inspectors.
• Follow-up activities including provision of outstanding requests, handover to the CAPA Lead.
• Review and provide input/feedback on external audit summaries generated by other team members
• Lead Regulatory Authority Site Inspections support activities including:
• Preparation activities such as liaising with the client: identifying, escalating and mitigating any risks; preparing operational teams and investigational site staff, as needed.
• Support operations during the inspection conduct, such as review of any document requests, liaising with the client and attending the inspection on site as needed.
• Follow-up activities, such as liaising with the client and/or regulatory inspectors, finalizing and distributing daily summaries and handover activities to the assigned CAPA Lead.
• Lead inspection readiness team activities for projects/programs/assets

CAPA MANAGEMENT Responsibilities

• Lead Quality Issues investigations, root cause analysis (RCA) and resulting CAPAs management, including o Lead RCA and investigation meetings with relevant operational responsible persons,
• Liaise with the client, providing input on CAPA plans and
• Ensure ICON’s QMS/ tracking system updated with the appropriate information and documentation
• Lead CAPA management for internal & external audits & inspections including:
• RCA and investigation meetings with relevant operational responsible persons,
• Liaise with the client and/or regulatory inspector, providing input on CAPA plans and
• Ensure ICON’s QMS/ tracking system updated with the appropriate information and documentation
• Assist with the tracking of incoming QIs and QI triage and assessment process.
• Figure out effectiveness check requirements for responsible CAPAs, track and complete effectiveness checks as required.
• Assist with the review of effectiveness check requirements, effectiveness check plans and effectiveness check outcomes
• Assist Q&C Management / Director with oversight of open CAPAs, trending and analysis of CAPAs and metrics reporting. This includes providing summary information/input to Governance reports.

GOVERNANCE Responsibilities

• Support quality and regulatory compliance and escalation management processes including ensuring the timely escalation of suspected scientific misconduct and potential serious breach notifications.
• Lead case management of suspect scientific misconduct, risk cases & potential serious breach investigations.
• Manage ongoing investigations based on the specifics of each individual case in a structured manner and as per relevant work instructions
• Provide ongoing updates on actions and results as needed to the core investigation team and relevant senior management across ICON including Quality & Compliance.
• Support ICON functions and client for regulatory reporting such as regulatory reporting documentation as needed.
• Generate and distribute internal case summaries for GRC Management.
• Maintain central repository for case summaries and all relevant supporting documentation o Liaise with clients and regulatory authorities as needed.
• Liaise with operations for site due diligence requests for information.
• Maintain case trackers for different case types including suspected scientific misconduct, risk cases and potential serious breach.
• Lead related process improvement initiatives within Q&C and the business as well as with clients as needed.

Experience, skills, knowledge requirements

• EU/APAC: Experience in Pharmaceutical and/or GXP environment including in-depth knowledge and experience in Quality Assurance auditing and/or with relevant regulatory compliance /Quality System , including quality system development and leading system development projects.US/LATAM/CAN: A minimum of 3 years’ experience in Pharmaceutical and/or GxP environment and Quality Assurance auditing
• Thorough knowledge of relevant GxP regulations and accreditation requirements as relevant, including but not limited to GCP, GMP, GDP , GVP, GLP, 21CRF Part 11, CAP, CLIA and any local regulations as applicable to the business
• Ability to review and evaluate clinical data/records/systems/processes
• Thorough knowledge of the clinical development process
• Thorough knowledge and experience in performing and leading Root Cause Analysis.
• Ability to handle complex issues and related CAPAs, including leading large cross functional teams, task prioritization, and project management as needed.
• Demonstrated coaching, mentoring & training skills, including the ability to give constructive feedback
• Ability to work as part of a team
• Highly developed problem solving skills, and the ability to resolve difficult situations.
• Well-developed interpersonal and communication skills (oral and written) with prior experience conducting presentations or facilitating meetings.
• The ability to liaise effectively with internal and external parties.
• Oral and written fluency in the English language is required in order to communicate with personnel at multiple levels across the organization.

Benefit of Working with ICON:

Other than working with an excellent team of passionate and ambitious people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

Process

Technical and competency selection:

When you spot an opportunity you’re passionate about and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your proficiencies – for example, delivering excellence.

Interview

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

Offer

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.