Quality Control (QC) Systems Lead

Employer
Grifols
Location
Dublin West, Dublin
Salary
Negotiable
Closing date
22 Dec 2021

View more

Sector
Scientific
Salary Range
Permanent, EUR, €40,000 - €49,999, €50,000 - €59,999
Job Type
Permanent
Hours
Full-time
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Job Details

Quality Control (QC) Systems Lead is required for the QC department at Grifols Worldwide Operations (GWWO). The role is responsible for the maintenance, development, transfer and installation of all related QC systems adhering to GMP compliance. All compendial and regulatory guidance and updates must be reviewed and implemented where relevant.

This role offers a chance to work in a state-of-the-art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.

Reports directly to the Quality Control (QC) Manager of GWWO.

 

RESPONSIBILITIES

  • Liaise with QC Chemistry, QC Microbiology and Incoming QC teams to ensure tasks and goals achieved
  • Maintain / improve GMP compliance in daily QC operation
  • Review of regulatory/compendial guidelines and regulatory body updates to ensure QC operates in a fully compliant manner
  • Ensure data integrity requirements implemented at QC
  • Ensure QC equipment including computerised systems are qualified in line with site procedures and regulatory requirements
  • Responsible for QC equipment qualification procedures, validation plans and lifecycle management.
  • Development of relevant QC SAP systems and procedures
  • Creation, review, update and approval of QC specific SOPs to ensure all aspects of compliance are adhered to
  • QC metrics monitoring and creating required reports
  • Drive process efficiencies, tracking and reporting on improvements including cost, productivity and waste/rework
  • Support and lead any projects impacting the Quality Control department such as Method Transfers, Process Improvement or harmonization
  • Drive and oversee process/product/deviation/OOS investigations related to the QC systems and processes as needed
  • Responsible for the implementation of Corrective and Preventative actions related to QC
  • Responsible for QC support of the annual product review process
  • QC representative on change control review team to assess impact of all change controls at QC and manage implementation activities
  • Ensure regular Quality interaction with other cross functional departments within GWWO and Grifols sister sites
  • Proactive engagement with stakeholders (internal and external) to ensure requirements are delivered on time and on budget
  • Development of QC training systems and carry out training of QC personnel when required
  • Maintain, monitor and report relevant QC metrics and KPIs
  • Lead QC inspection readiness for regulatory inspections
  • Represent the QC department in any regulatory, corporate or internal audits as required
  • Report out to management, senior management and leadership teams on all ongoing QC activities
  • Act as a delegate for activities performed by the QC Manager where requested

 

 

 

REQUIREMENTS

 

 

  • Proven success working well in a team environment with flexibility to react to changing business needs
  • Ability to work on own initiative
  • Ability to handle multiple projects and deadlines
  • Excellent verbal and written communication skills. Must be able to read, write and speak English
  • Strong technical writing skills
  • Strong interpersonal skills with the ability to interact with all levels of personnel in a professional manner
  • Demonstrated problem solving skills
  • Demonstrated project management skills
  • Strong Decision-Making skills
  • Method Transfer and qualification knowledge
  • Equipment and computerised system Qualification Experience
  • Data integrity regulatory understanding and knowledge
  • Competence with SAP
  • Competence in Microsoft packages; specifically, Word, Excel and Powerpoint
  • Experience with computer software validation
  • Experience in HPRA/FDA regulatory inspections
  • Degree or equivalent in chemistry, biochemistry, pharmaceutical science or related field
  • 5 years progressive experience as an individual contributor in a GMP laboratory environment

 

 

Company

Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction. www.grifols.com

Grifols Plant

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Location
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