Abbott QA Audit and Compliance Manager in Moscow, Russia
Primary Function/Primary Goals/Objectives
The role of the of Audit and compliance Manager function is to manage on-site audits and Quality Questionnaires, related to Suppliers, Third Party Manufacturers & affiliates for GxP and Pharmacovigilance (PV), self inspection, regulatory update and site readiness for AQR and external audits that fall under the responsibility of EPD QA. The scope is Suppliers and Third Party Manufacturers that provide materials, services and products to Russia EPD. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, CRO and third party manufacturers who provide intermediate/final products to Russia EPD.
Reporting to Regional QA Director, key responsibilities will include:
Manage on site GxP & PV audit for regional and local Suppliers and Third party Manufacturers and affiliates.
All activities required to plan, prepare for, conduct, report and close the assigned audits.
Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.
Manage Quality Questionnaire for Suppliers, affiliates and Third Party Manufacturers regionally
Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for affiliates, regional supplier and TPMs.
Timely information on the audits to management and stakeholders.
Escalation of any critical findings or negative audit outcomes to regional EPD senior management, in line with the applicable policy and procedures.
Reviewing any Quality Questionnaires returned by the Suppliers/TPMs and resolving any issues.
Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.
Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
Responsible for supporting creation and implementation of continuous improvement initiatives.
Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
Provide support to regional EPD plants, affiliates and Contract Operations QA in the timely resolution of issues related to Suppliers and Third Party Manufacturers.
Discuss with and agree with the affiliates, Suppliers and TPMs a timely implementation of corrective and preventive actions, as needed to prevent recurrence.
Implement and maintain efficiently self inspection QMS for commercial affiliates and manufacturing sites to provide comprehensive readiness of affiliate and manufacturing sites for AQR and external audits.
Provide regular local and international regulations update.
Bachelor Degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries
ISO, TUV Certified Quality Auditor or other international certification desirable.
At least 7 years in the Pharmaceutical Industry; and at least 5 years of GXP Auditing experience, with a minimum of 3 years Lead auditor experience in GxP, Pharmacovigilance or ISO
Knowledge and understanding of the relevant GxP, PICs, ICH, Pharmacovigilance and other relevant technical guidelines
Understanding of the WHO and other applicable regional and local regulations
Ability to communicate, understand and mentor individuals in highly specialized technical fields.
Project Management and troubleshooting skills
Advanced written and verbal skills in Business English
Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
Other requirements include:
Adaptability, Initiative, Integrity
Planning and Organizing
Perceptual and analytical problem solving relating to the removal of obstacles.
Ability to prioritize.
Ability to use Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making .
Willingness to travel
Strong communication and negotiation skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com