Auditor Good Clinical Practices GCP
Auditor Good Clinical Practices GCP
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$ 89520 - 134280
1 Vacancy
Job Description
At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse talented people to join Alcon.
In this role as an Auditor you will lead and conduct independent Good Clinical Practice (GCP) riskbased audits across all Alcon franchises to assure clinical related activities are conducted according to Alcon quality standards and applicable regulations. In this role you are responsible to perform audit metrics and rootcause analyses of noncompliances and provide guidance training and support to the business partners. Your audit types include Investigator Sites Vendors Systems and Documents (i.e. regulatory submissions) and other audits as assigned.
JOB FUNCTIONS
Plans conducts and manages GCP (remote or onsite) and or other type of GXP audits with a under limited supervision.
- Supports and contributes to the overall audit planning and scheduling process. Ensures assigned audits are tracked appropriately. Submits audit plan change control documentation as needed.
- Ensures audit observations are communicated appropriately to Auditee and Senior Management. Ensures escalation process of critical observations is followed. Prepare and distribute audit reports according to Alcon requirements and timelines.
- Reviews evaluates and approves proposed corrective and preventative action plans (CAPA) in collaboration with the responsible business partner.
- Provides guidance and advice to clinical teams on GCP related questions.
- Tracks trends interprets and presents GCP compliance data for management metric review meetings and for continuous improvement.
- Supports and prepares teams for regulatory inspections and/ or corporate audits as directed. Enter and track Health Authority inspection information and reports in database.
- Mentors and trains junior auditors. Provide technical guidance leadership and coaching of audit related activities. Performs auditor certification process and assessments for new auditors.
- Provides guidance review and approval of associated deviations (NCI & CAPAs). If necessary lead and support the investigation of deviations and other quality issues detected from any source. Accountable for CAPA follow up and verification activity jointly with Clinical Development.
- Provides QA support to Supplier Evaluation Teams as needed and conducts GXP audits as assigned.
- Stays current on activities in Clinical by reviewing list of ongoing studies and attending Study Review and Project KickOff Meetings.
- Supports additional CQA initiatives and other cross functional duties as assigned.
EDUCATION AND MINIMUM REQUIREMENTS
Bachelors Degree or Equivalent years of directly related experience (or high school 10 yrs; Assoc.6 yrs; M.S.0 yrs)
The ability to fluently read write understand and communicate in English
2 Years of Relevant Experience
Preferred Experience and Qualities
5 years experience in medical device and/or pharmaceuticals audits
35 years in GCP auditing role
Knowledge of ISO 14155 ICH 6 Medical Device EU and FDA regulatory requirements and Declaration of Helsinki.
Proven GCP audit track record.
Good Analytical Skills and Judgement
Advocate for exceptional quality and compliance standards does not compromise on customer expectations and regulatory requirements
TRAVEL REQUIREMENTS
As required up to 60 travel
OTHER DIMENSIONS AND SKILLS
Ability to assess / judge critical issues and initiate escalation.
Independently plan schedule audits and issue audit reports.
Plan travel and expenses within budget and submits T&E reports on time.
Contributes to annual budget planning.
Prepares and manages Alcon Audit Plan as assigned.
Skills/ Values/ Behaviors
Communicates Effectively
Collaboration
Situational Adaptability
Manages Conflict
Resourcefulness
Good Interpersonal skills
Demonstrated sensitivity and knowledge of cultural differences with experience in multicountry multicultural environments and demonstrated success with crossgeographically based cultural collaboration
HOW YOU CAN THRIVE AT ALCON:
- Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
- Collaborate with teammates to share standard processes and findings as work evolves!
- See your career like never before with focused growth and development opportunities!
- Alcon provides robust benefits package including health life retirement flexible time off for exempt associates PTO for hourly associates and much more!
Alcon Careers
See your impact at Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
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Total Rewards
Alcons Total Rewards programs are designed to align to incentives with business goals encourage the right values and behaviors and deliver longterm value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay which includes shortterm incentives and longterm incentives for eligible population. Our benefits program provides security for life events through life and disability insurance supports savings for retirement promotes good health and wellbeing and supports associates and their families during times of illness. To learn more about Alcons Corporate Social Responsibility including our Total Rewards click here
Pay Range
$89520.00 $134280.00Pay Frequency
AnnualAlcon is an Equal Opportunity Employer and participates in EVerify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.
Employment Type
Full-Time
Key Skills
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