External Manufacturing Quality Manager

З/п не указана
Опыт работы: Более 6 лет
График работы: Полный день
Занятость: Полная занятость
Компания: RB
Role Purpose

Responsible for the assessment of external manufacturers and service providers against approved RB standards and / or regulatory standards and guidelines.

To manage a portfolio of external manufacturing organizations to ensure compliance of RB products by working directly with the EMO’s and acting as the RB quality contact.

Responsibilities
  • Auditor supporting both External manufacturing and RB Internal or corporate audits as required based on competency.
  • Assessment and approval of external manufacturers to include auditing based in Russia and Europe, where required, with ongoing management of a defined portfolio.
  • Be the point of contact and direct interface with external manufacturers.
  • Management of activities associated with External Manufacturers to include review of documentation (PQ, PCS, BOM, MOM etc) and management of NPD, EPD and roll out conducting GFS.
  • Refers major non-standard and product quality issues to External Quality Manager Europe.
  • Supports Quality manager in CEP investigations.
  • Interface with cross functional teams to support External Manufacturing activities: Regulatory, R&D, Technical, Planning, Activity Management, safety and medical teams were necessary.
  • Support the site in delivering in-house ad multiple regulatory standards of compliance to best business advantage.
  • Maintaining competency to required levels.
  • Support delivery of team KPI’s.
  • Support in the training of other team members where required and appropriate.
  • Supports and participates (as required) in inspections by external regulatory authorities.
  • Creation and approval of Quality Records (Deviations, Change controls, Complaints etc)

Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility

Key challenges
  • Resolving issues regarding quality to the point of stopping production operations and freezing stock as applicable.
  • Ensuring quality requirements and production requirements are considered without detriment to either.
  • Product release or reject recommendations to QM in the event of significant quality issues.
  • Facilitates resolution of quality issues
  • Engaging cross functional teams to deliver on quality issues managed by EMQ EU.
  • Ensures deviations captures appropriate CAPA actions and are fed into the quality system.
  • Ensuring quality requirement and production requirements are considered.
Skills and experience
  • Desirable experience with anti-septics or liquids manufacture.
  • Experience and an understanding of Quality Management Standards such as ISO13485, ISO22716 and EU GMP
  • Good knowledge and experience in Microsoft applications and office 365.
  • Good leadership skills.
  • Degree or equivalent in a relevant scientific discipline is desirable, suitable experience will be considered.
Хочу откликнуться
<
>