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Sr Compliance Specialist


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Location: Fort Worth TX

Company Name: Novartis

Occupational Category: 13-1041.00,Compliance Officers

Date Posted: 2020-02-24

Valid Through: 2020-03-25

Employment Type: FULL_TIME

Description:

Job Description •The role of the Sr.
Compliance Specialist is to provide expertise, guidance, and leadership to the entire facility through maintaining Quality Assurance programs (i.e.
Internal/External audit management (development of plans, scheduling, schedule attainment, audit change control, master data maintenance, periodic reporting), Annual Product Reviews, CAPA, Regulatory Reviews, Post market Actions Management, FAA/Escalation Management, etc.) and compliance to regulations and established standards.
•Provides expertise and guidance to the entire facility, including management, in interpreting the statutory regulations/guidelines (i.e.
QSR, ISO, JPAL, AAMI, ANSI, MDD, MDR) internal procedures (SOPs, PMs, CD forms, etc.)
•Corporate procedures to ensure compliance.
•This also includes conducting reviews and regulatory assessments of Quality System documents to ensure compliance.
•Through these reviews, it may be necessary to use statistical methods to identify the risk level of the issue in order to make the correct recommendations.
•Develop and maintain quality assurance programs, policies, and procedures ensuring that performance and quality of the products conform to established standards, such as QSR/GMP, ISO 13485, ISO 14001, JPAL, MDD, AAMI, ANSI, MDR Corporate policies and procedures.
•Establish and maintain programs for ongoing monitoring and improvement of the effectiveness of the Quality System.
•Provides leadership as a team member and as a liaison between the facility and internal /external auditing bodies, including, but not limited to, Corporate, Health Authorities (i.e.
FDA, ANVISA), Notified Bodies (i.e.
TUV), Ministry of Health (i.e.
Japan), etc.
•This includes development of global audit plan, schedule, schedule attainment, audit change control, master data maintenance, periodic reports, preparing the facility for the audit, assisting in the audit as well as trending and tracking of any regulatory audit findings.
•As necessary, will review CAPA responses for the appropriate facility.
•Executes audit plan, as assigned, including the pre-audit meeting, perform the audit and post-audit meeting using generally accepted auditing techniques and tools as well as the team concept, which utilizes personal interaction skills.
•Assure completion of audit plan to ensure facility compliance and readiness for regulatory and corporate audits.
•Trend and track corporate internal/external audit (findings, audit plan, schedule, and schedule attainment) and FAA / Escalation / CAPA for management review meetings and follow-ups.
•Develop and coordinate the communication with MoH's and submit statutory regulatory reports (FARs, FSN, FSCA, etc.).
•Administer electronic system to include master data maintenance for audit, Escalation, Field action Assessments, etc.
•Provide training for referenced electronic systems.

Alcon is an Equal Opportunity Employer and participates in E-Verify.
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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
Equal Employment Opportunity Posters:
If you’d like to view a copy of the Alcon’s affirmative action plan or policy statement, please email alcon.er@alcon.com.
EEO Statement Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment.
We do not 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.

Minimum requirements •Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs.; Assoc.
• 9 yrs.; M.S.
• 2 yrs.; PhD+0 yrs.).
•The ability to fluently read, write, understand and communicate in English.
•5 Years of Relevant Experience