Oferta pracy

Specjalista Jakości - Farmaceuta

GSKAbout the company

  • Warszawa

    Warszawa, Masovian
  • Offer expired 15 days ago
  • Remote recruitment
  • contract of employment
  • full-time
  • specialist (Mid / Regular)

Your responsibilities

  • Handling quality complaints, registering them in the system, prioritizing, contacting with factories, explaining complaints, and resolving them. Sending complaint samples. Creating local procedures for the handling quality complaints.

  • Coordination Consumer Healthcare documentation, adding new documentation, handling SOP Index Tracker, giving opinions, archiving checking and approving Standard Operating Procedures and Working Instruction.

  • Support LOC NPI process through the Change Management Process and GMM codes management

  • Provide support to LOC QMS activities in activities that maintain/develop the LOC Quality Management System and develop the Quality culture such as implementation of Quality Modules.

  • Administrative support for local Training/ on-boarding activities, creating training matrix, coordination preparing Job Description by LOC Team

  • Local Repacking: Support Quality Manager in all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures to ensure timely QA approval before initiate any re-packing activity for MDD products

  • Supporting Quality Manager in preparing and handling Quality Agreements and TTS

  • Participate in investigation of complaints, deviations, and product incidents and recalls ensuring that all investigations are thorough, complete, identify root cause, and assign appropriate CAPAs and is accountable for team metrics ensure effective liaison with LOC third party and other business partners on quality related topics.

  • Support Responsible Person (GDP) the ‘GDP administrative release’ process of RP-released batches of medicinal products, including monitoring and evaluation of Batch Release processes.

  • Support and/or perform Independent Business Monitoring (IBM) and Self-Inspections (SI), in full compliance with GSK QMS, GMP and GDP-requirements.

Our requirements

  • Master in Pharmaceutical sciences, Certified Pharmacist , with 2 years minimum experience in pharmacy or pharmaceutical wholesale

  • Quality experience in the pharmaceutical industry, in a quality function.

  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.

  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Continuously looking for opportunities to learn, build skills and share learning.

  • Sustaining energy and well-being.

  • Building strong relationships and collaboration, honest and open conversations.

  • Able to work effectively in English

  • Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

  • Valid driving licence

What we offer

  • Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer

  • Opportunity for professional development and acquiring new skills set in a top-level professional environment

  • Career at one of the leading global healthcare company with modern employer mindset, corporate culture and values

  • Corporate culture based on our values: patient focus, integrity, respect and transparency.

  • Competitive salary, bonus plan and healthcare benefits

  • Supportive & friendly working environment

  • Company car

  • Benefits

  • private medical care

  • life insurance

  • remote work opportunities

  • retirement pension plan

  • leisure zone

  • holiday funds

  • employee referral program

  • charity initiatives

  • annual bonus

  • Multisport

Job Description Summary

The job exists within the commercial Local Operating Companies to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met.

The job holder is expected to support the Country LOC Quality Lead, Quality Managers RP/QP where QA Specialist needs to provide support to LOC QA Operational related to GDP batch release, complaint handling, repacking, training and documentation and provide support to the implementation and maintenance of the LOC Quality Management System.