Quality Assurance Lead

Quality Assurance Lead

Baxter International

Dublin, Ireland

SUMMARY

The Quality Assurance Lead is responsible for carrying tasks pertaining to compliance and product quality. Providing quality oversight and ensuring compliance with regulatory requirements. This role is required to collaborate with all relevant departments to ensure that key quality systems are operated and maintained in a compliant manner. This will include batch disposition, documentation management and approval, product record review, investigations, complaints, change controls, audits, agreements, stability, QA support for validation activities and regulatory support.

ESSENTIAL DUTIES AND RESPONSIBILITES

  • Ensure compliance with cGMP, corporate standards/Baxter Quality Systems (PQS), site policies/procedures, regulatory requirements and industry standards;
  • Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies. Assures completeness in terms of root cause, action taken and CAPA.

Annual Product Record Reviews (APQR):

  • Work with areas/subject matter experts to ensure timely evaluation and completion of final reports;
  • Facilitate creating and maintaining the schedule for completion of APQRs;
  • Gather, collate and review data and supporting documentation associated with compiling APQRs.

Batch Disposition:

  • Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and supports efficient production;
  • Review and Maintenance of Merlin Component Files and Finished Product Codes;
  • Approval of Order Entry Error Investigation Reports.

Changes/New projects/Periodic reviews:

  • Support the introduction of new products;
  • To review and approve qualification/verification protocols/reports, procedures, specification, validation deviations and project validation/plans as required;
  • Support the timely release of equipment, utilities, facilities, and computer systems following the execution of test protocols;
  • Key member of Quality Risk Management and Operational Excellence to improve efficiencies and to promote continuous improvement. Identify and implement continuous improvement opportunities;
  • Ensure that change controls are compliant with applicable procedures and maintain a validated state.

Customer Complaints:

  • Co-ordinate and assist with the analysis and investigation of customer complaints;
  • Utilize both Global and local systems for management, investigation and reporting of customer complaints;
  • Ensure all complaints are closed within specified timeframes;
  • Trending and reporting of Customer Complaints.

Stability:

  • Set up Merlin Component Files for Drugs, Fluids, Devices, Additives and Ancillaries (where used) using available Product and Stability information;
  • Facilitate and maintaining the schedule for Annual Stability Review Programme.

Metrics:

  • Support trending and compilation of investigation/system reports and customer complaints in a timely manner.

Inspection/Audit:

  • Ensure inspection readiness in work completed;
  • Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring site is always audit ready;
  • Support and participate in site self-inspections and Gemba walks;
  • Review and approve internal audit reports;
  • Conduct audits as per internal audit schedule.

Documentation Management:

  • Manage and maintain the Documentation System. Manage of site archive, storage, retrieval and destruction processes;
  • Review and approval of Quality documentation;
  • Supporting all departmental administration systems as required.

Other:

  • Compilation of reports in a timely manner as requested;
  • Providing back up on control and issue of Quality Documentation;
  • Oversee and administer Change Controls;
  • Implementation, execution and administration of non-conformances;
  • Complete Inventory Management System transactions as required;
  • Complete additional Quality related tasks and assignments as required by the department manager;
  • Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable;
  • Compliance to Environmental Health & Safety (EHS) requirements.

EDUCATION AND/OR EXPERIENCE

  • Bachelor's degree in Chemistry, Biology or a related scientific discipline;
  • Proven experience working in a GDP/GMP environment, preferably minimum of 3 years’ experience;
  • 1 years’ experience in a leadership role;
  • Experience in dealing with Regulatory Compliance desired;
  • Experience of the following would be beneficial:
    • Leading Teams;
    • Risk Management;
    • Experience of aseptic technique;
    • Lean manufacturing experience;
    • Experience of implementing changes and process development;
    • Computer skills: MS Office, Excel, Visio and Track wise Quality management software would be advantageous.

SKILLS

  • Good problem solving and investigation skills would be beneficial;
  • Good professional standards, meticulous and demonstrates good attention to detail;
  • Ability to work under pressure and meet deadlines;
  • Highly motivated self- starter and team worker;
  • Ability to work in a team-based environment and ability to manage a wide range of specific tasks;
  • Excellent organisational, coordination and communication skills;
  • Meticulous in attention to professional standards;
  • Respond well to time constraints;
  • Good influencing and interpersonal skills;
  • An ability to work in a dynamic, fast-paced and goal driven environment. Be self-driven.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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