Job Title:

Commercial QA Specialist

MAIN PURPOSE OF JOB

Manage Quality Systems related to commercialization and distribution of ANI products in the country. Comply with Abbott Policies and procedures, in alignment with local regulatory requirements.

MAIN ACCOUNTABILITIES

Assure Quality policies and regulatory requirements implementation through coordination of new requirements evaluation and implementation in local documentationAssure the annual internal auditing programs are prepared and executed in order to monitor the implementation and compliance with GxP principles, proposing corrective measures if necessary and regularly appraise the effectiveness and application of the Quality Assurance systemAssure suppliers periodic qualification according to regulatory and Abbott standards and requirementsManagement of complaints, management of QA Hold and Product Actions; collaborate in the management of exceptions, CAPA, counterfeiting and parallel import events and assure management of Exception, CAPA, QA Hold and Product action as appropriateAssure GMP/GDP Affiliate training system implementation and maintenance through the use of appropriate systemAssure GMP /GDP affiliate documentation availability through the standard documentation platformEnsure Controls are applied on promotional materials and samples management by relevant stakeholdersEnsuring that process controls for over-labelling / packaging processes are maintained and systematic and assure GMP requirement implementation and control the product finishing Control operations wherever applicableResponsible for maintaining quality dashboard and matrix within all countries in scope and preparation of Quality Management Review as per the defined frequenciesPutting in place and in use a continuous audit readiness program for affiliate to ensure successful Abbott Affiliate Audits

ACCOUNTABILITY

Accountable for overall compliance of the QMS for AN within the affiliate.Release of products to Market as per the AN policies and proceduresTimely reporting of complaints and adverse events.Close follow up of reports and KPIsDeveloping and maintaining local SOPs.Following relevant Abbott policies and procedures / local regulations.Continual review and improvement of the QMS and quality related activities within the AN affiliate.

BACKGROUND/EDUCATION

Degree (BSc or equivalent) in a technical / engineering subject, or life sciences.Knowledge and experience gained within a QA Engineering / regulatory environment.Experience with ISO9001 (experience of auditing to ISO13485 preferred).Thorough understanding of GDP, GMP, ISO9001 and ISO13485.QMS experience in Pharmaceutical or Nutritional Industry.Excellent written and verbal communication skills.Excellent organizational skills and strong attention to detail.Competent use of Microsoft Office.Ability to analyze and interpret numerical data.Good knowledge of written and spoken English