pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.


Senior Specialist- QA

To assist in facilitating the effective implementation of the global QA program across one or more VDCs, supporting the activities of VDC QA Coordination.  Works across the Quality Department and designated VDC(a) to support the global QMS. Supports Operational Quality & Strategy and Cencora VP International Quality as directed.

Location- Poland/Portugal

Your Job

  • Input to, and review of annual audit program and specific audit plans relevant to designated VDC(s)
  • Support the development of appropriate and effective CAPA plans related to deviations, audit findings, non-conformities and other quality issues including risk assessment, root cause analysis and action planning
  • Monitor progress of the VDC(s) versus agreed CAPA plans, escalating issues as needed
  • Support maintenance of the VDC-specific training matrix
  • Support the document management lifecycle for designated VDC(s), including advising on content to ensure compliance with the QMS and applicable regulatory requirements. Keep the VDC aware of becoming due deadlines e.g. periodic document reviews
  • Support the change control process for the designated VDC(s)
  • Maintain KPI and other QMS performance metrics related to the designated VDC(s), making the VDC(s) aware of trends and issues that require attention
  • Coordinate regular meetings with VDC stakeholders
  • Support the VDC(s) and Quality Strategy to identify opportunities for process improvement. Contribute to implementation of process improvement initiatives
  • Support the global QMS/eQMS
  • Participate in other departmental initiatives as requested
 

Your Profile

  • Autonomous, concentrated and high-quality work.
  • Ability to work in a team.
  • Sense of responsibility.
  • Very good command of English (written and spoken).
  • Minimum of 5 years in quality role, preferably with quality management / change management content.
  • Minimum of a bachelor’s degree in a scientific discipline​.
  • Organisational skills and structured thinking.
  • Good analytical skills and lateral thinking.
  • Good communication skills and ability to work in a Team and cross functionally with the VDCs ​and other business partners.
  • Knowledge of pertinent legislation / regulatory framework (ISO 9001 requirements preferred).
  • Very good command of written and spoken English.
  • Results driven.
  • Experience working remotely in EU time zone preferably Poland/Portugal/Bulgaria.

We offer

  • A collaborative and diverse work environment that values innovation and inclusivity.
  • Opportunity to join a fast paced growing Global MNC and conquer exciting and varied challenges alongside a talented team
  • Ability to work independently and collaborate effectively in a global, cross-cultural environment.
  • Flexible working hours striking a good work life balance
  • Business interaction with nearly all branches of the company across 5 continents
  • A broad range of initiatives for personal development and professional training


If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

 

Agencies only by prior agreement for the specific job opportunity.