Allergan Commercial Quality Specialist in Dublin, United States

Commercial Quality Specialist

Dublin, Leinster, Ireland at https://agn.referrals.selectminds.com/jobs/5719/other-jobs-matching/location-only

Jun 18, 2018Post Date

180935Requisition #

Position Summary:

This position, reporting to the Director, Commercial Quality, will provide Quality support for all on -site (International Supply Chain) departments and regional teams, their primary focus is to ensure that all activities are carried out as per Good Distribution Practice (GDP) guidelines. This position will be involved with activities such as auditing, deviation review, change control and review and update SOP's and training documentation. This position will also undertake project management activities with regards to new business, new products, new processes and to drive continuous improvement within the business.

Responsibilities:

Primary duties and responsibilities of the position are as follows. Other duties may be assigned.

  • Responsible for the maintenance of the Allergan Pharmaceutical International Ltd (APIL) Quality system as part of the local/regional systems feeding into the Corporate Quality system, compliant and relevant GxP's, ISO 13485 and relevant local legislation

  • Support QA requirements and implement as appropriate for the Supply Chain functions

  • Ensure alignment between local Quality SOP's and regional SOP's and Corporate Standards, Policies and Procedures through review and update as required

  • Responsible for document controller functions on CORAL and to provider cover for the archiving administrative function

  • Support the Change Control & risk assessment system within Supply Chain and EAME region

  • Conduct internal audits & self inspections of local & regional QMS to evaluate compliance, providing a non-conformance report to Management team and Director, Commercial Quality

  • Maintain CAPA / Deviation program initiate Corrective Action plans with department managers

  • Conduct GMP and GDP training for all local personnel and maintenance of training records for internal staff

  • Provide monthly KPI reports to management including audit results and status of Corrective Actions

  • Support the International Supply Chain management representative for recall situations

  • Release product for distribution where country of destination is not listed on ECR

  • Ensure all CMO's meet the requirements of Allergan's Quality Standard, Policies and procedures

  • Perform audits on all Supply Chain vendors to validate compliance with Quality System and Service Level Agreements

  • Support the development of test protocols for cold chain packaging and shipping system qualification

  • Quality facilitator for the Supply Chain department supporting quality improvement initiatives

  • Implementation of the falsified medicines directive

Position Qualifications:

  • The equivalent of 3 years college education in a medical/scientific related field. At least 3 years' experience in quality related or production in the pharmaceutical or medical device industry

  • Previous administrative experience, working at a senior level, ideally in a pharmaceutical or medical device company

  • Previous experience with ISO standards and GMP quality systems required for pharmaceutical/medical device industry

  • Excellent administrative skills, including good proficiency in Word, Excel and Powerpoint

  • Willingness to learn new additional software packages as required

  • Ability to work through procedures rather than instruction

  • Manage own workload without supervision

  • Demonstrate flexibility in responding to urgent requests

  • Enthusiasm and quality improvement orientation

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.