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Quality Assurance Officer (GDP)

Quality Assurance Officer (GDP)

Curium Live ForwardPraga, CZE
Před 24 dny
Popis pozice

Summary of Position

  • Ensure compliance with Good Distribution Practice (GDP) regulations to maintain product quality and integrity throughout the supply chain.
  • Implement, maintain, and oversee the Quality Management System to ensure systems, procedures, controls, risk management, and continuous improvement meet regulatory requirements for aspects relating to Quality Assurance, Regulatory Affairs, Pharmacovigilance, Product distribution and importation (as applicable).
  • Manage quality events such as customer complaints, deviations, recalls, and returns, implementing CAPA as necessary.
  • Lead / host and conduct internal and external audits and inspections, and provide training to uphold GDP standards and regulatory compliance.
  • Assist in inspections by regulatory authorities.

Essential Functions

Quality Management System :

  • Monitor and ensure compliance with regulations, quality standards and risk mitigation measures within the supply chain.
  • Develop, implement, and manage GDP-related SOPs, policies, records, and checklists.
  • Coordinate with departments regarding the implementation of systems, procedures, and controls.
  • Ensure that all processes and their systems for GDP compliance are robust to support business continuity and assure continuity of supply of all licensed Curium products on the customers’ markets.
  • Monitor and report trends and KPIs to senior management through periodic management review.

    • Quality events :

  • Oversee the receipt of customer complaints by Customer Service.
  • Coordinate complaint investigation by Manufacturer’s QP / Quality Department or the Pharmacovigilance department, in case of respectively a quality complaint or medical complaint.
  • Investigate and, if applicable, coordinate the investigation by third party to resolve GDP-related deviations and customer complaints, implement CAPA as needed.
  • Manage interceptions, recalls, and returns.
  • Maintain accurate and complete records of quality documentation.
  • Monitor and communicate trends to senior management through periodic management review.

    • Training :

  • Provide GDP training and guidance to Customer Services, logistics partners, and other relevant stakeholders.
  • Oversee the process and system for recording and monitoring training records and documentation including qualification status.

    • Audits and inspections :

  • Develop internal and external Audit Plan including budget, planning, risk assessment and resource management.
  • Conduct internal audits, external audits (service provider, etc.), and manages documentation, and addresses non-conformances related to GDP.
  • Lead or host external regulatory inspections and audits to ensure compliance.
  • Lead or host the local regulatory (SUKL) inspection, as required, and prepare response to inspection / audit observations.
  • Coordinate, assess, and track responses to inspection / audit observations from internal and external (regulatory, service providers, etc.) audits.

    • Supplier, Service provider (outsources activities) and Distributor oversight and compliance :

  • Establish and maintain Quality Assurance Agreements with supplier, service provider and distributor to ensure compliance with legal and GDP regulatory and company quality requirements.
  • Assess, approve and oversee supplier, service provider and distributor for their regulatory and GDP compliance and anti-counterfeiting measures.
  • Perform cross checks on purchase orders to Wholesale authorization and applicable licenses, to confirm that the product can be supplied in the country for the intended purpose.

    • Requirements

    Education :

  • University degree in pharmacy or equivalent.
  • Postgraduate degree in related subjects preferred, such as pharmaceutical technology or quality, though equivalent relevant experience will also be considered as important.
  • Practical knowledge and training in current applicable pharmaceutical GxP requirements (eg. GVP, GMP, GDP) is a requirement.
  • Formal training as a QMS Lead Pharma Auditor would be an asset but is not strictly necessary.
  • Formal training as an EU Responsible Person (RP) or CZ / SK Qualified Person for Distribution would be very desirable.

    • Experience :

  • Minimum 5 years’ QMS or QA auditing, or other relevant work experience (eg. pharmacovigilance) in the Czech, Slovak, Netherlands or other European pharmaceutical and / or biotech industry.
  • Leading and / or participating in GMP, GDP or GVP audits for the Czech, Slovak or wider European pharmaceutical industry.
  • Knowledge of managing and setting up controlled document management systems as part of a pharmaceutical QMS.
  • Minimum basic knowledge of the drug development process.
  • Demonstrable knowledge of how Pharmacovigilance processes, GVP regulations and guidelines work in a pharmaceutical QMS.
  • Personal direct involvement in receiving regulatory inspection (eg. SUKL, IGJ or EMA) is an asset.

    • Preferred Skills / Qualifications :

  • Fluency in written and spoken Czech and English is a requirement whilst knowledge of another European or international language (such as Spanish, French or Dutch), would be an asset.
  • Good and effective interviewing, oral presentation, communication and other interpersonal skills.
  • Personal flexibility and ability to frequently travel nationally or internationally up to 10-20% of the time.
  • Excellent analytical, problem-solving and decision-making skills.
  • Able to demonstrate responsibility, maturity and project leadership in a crisis.
  • Capacity for independent, well-organized, correct and punctual work-delivery.
  • Ability to follow strategy, changing direction rapidly if required in order to achieve quality objectives.
  • Supervisory skills that allow the delivery of team tasks and objectives on time and as required.
  • Intermediate to advanced computer and software skills (eg. SAP, MS Dynamics , MS Office) are required.

    • Relationship with Others :

  • Internal : Curium Europe and Curium International staff including Regulatory Affairs, Quality Assurance, Finance, Transportation, Medical Information, Pharmacovigilance and Commercial staff. Reports directly to the Sr. Quality Assurance Officer / Responsible person of CITBV with a dotted reporting line to the VP, Shared Service Centre, Prague.
  • External : Customers, Auditees, Service providers, Partners, Distributors and Regulatory Authorities (IGJ and / or SUKL).

    • Scope of position :

  • The role is office-based but may require a substantial amount of travel (approx. 10-20% of the time).
  • The travel would be mainly to Petten in the Netherlands but may also include supply chain and partner audits internationally.

    • Country Specific Requirements :

  • The person must be an EU citizen and reside within a commutable distance of the Czech office in Prague.

    • Benefits

  • hours of vacation (equivalent to 25 days)
  • 5 sick days per year
  • Annual Bonus
  • Spot Bonus
  • Equal gender pay
  • Cafeteria Benefity (online benefit portal) - CZK net / month
  • Cafeteria Compensation Bonus (after trial period) - CZK gross / quarter
  • Flexible start and end of working hours
  • Home office - max 3 days / week
  • Meal card contribution of CZK / day worked (% paid by Curium)
  • Multisport card (optional benefit through the cafeteria system)
  • Contributions to pension (3% from salary)
  • Employee referral bonus program
  • Contributions to ACCA / CIMA / ICU qualification
  • Financial support for upskilling qualification
  • Contributions to accident and life insurance (% paid by Curium)
  • Company events and activities (social events, volunteering, and team building)
  • Coffee, variety of tea, fruit and vegetables daily at the workplace
  • Friendly international environment
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    Quality • Praga, CZE