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QC Chemistry Analyst

Employer
Grifols
Location
Dublin West, Dublin
Salary
bonus, health insurance , 25 days hols
Closing date
22 Dec 2020

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Sector
Scientific
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Job Details

QC Chemistry Analyst is required for a new purification and aseptic manufacturing plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).

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.

Reporting directly to the Quality Control (QC) Chemistry Supervisor of Grifols Worldwide Operations (GWWO).

 

RESONSIBILITIES:


· Carry out raw material, in-process and finished product chemistry and immunochemistry analysis.
· In-process and finished product QC including protein and excipient analysis including analytical techniques such as Spectrophotometry, Immuno-electrophoresis, HPLC, GC, AA and Flame-photometry.
· Raw material QC including Karl-Fischer, FT-IR and NIR techniques.
· Testing carried out in relevant fumehoods / safety cabinets as required.
· Ensure laboratory processes, equipment and services are installed and qualified appropriately.
· Ensure laboratory equipment and services maintained in an operational (and safe) state.
· Participate in the verification, validation and technical transfer of analytical testing procedures.
· Ensure that all cGMP, company specifications, procedures and guidelines are followed.
· Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
· Investigate Non-Conformances and actively lead subsequent corrective actions as required.
· Participate in and responsible for QC related CAPA's.
· Adhere to QC documentation system and prepare and review document change requests as required.
· Develop, improve and implement QC procedures, processes and systems.
· Support projects and continuous improvement initiatives within the Quality department and other functional areas.
· Participate in international project teams relating to QC and wider quality activities and travel maybe required.
· Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times.
· Prepare for and support regulatory and internal inspections/audits.
· Provide hands-on guidance and training when needed.
· Ensures area of responsibility is maintained in a state of compliance and audit readiness.
· Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.
· Flexibility and willingness to carry out shift work when required.


KNOWLEDGE/SKILLS/QUALIFICATIONS:


· Knowledge of and proficiency in a wide array of current analytical techniques including HPLC, Spectrophotometry and Electrophoresis.
· Knowledge of and proficiency in the use of analytical instruments including troubleshooting skills.
· Ability to carry out a wide array of Standard Operating Procedures.
· Experience with investigating and determining root cause of Out of Specification and Out of Trend events and writing thorough reports regarding the investigational findings.
· Interpret and apply applicable regulatory guidelines.
· Excellent verbal and written communication.
· Fluent in both written and spoken English.
· Must have strong technical writing skills.
· Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
· Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
· Bachelor's degree in Chemistry, Biochemistry or closely related scientific field.
· Requires a minimum of 2 years of related experience.

 

DESIRABLE:

 

  • Knowledge of specific product analysis (e.g. IC, AA, GC, Flame-photometry and Kjeldahl techniques) is a distinct advantage.
  • Knowledge of raw material analysis (e.g. Karl-Fischer, FT-IR and NIR techniques) is a distinct advantage.
  • Experience with SAP.
  • Experience in method transfer and verification/validation.
  • Experience with statistical analysis including use of Minitab.
  • General knowledge of pharmaceutical plasma-derivative company process, equipment and their chemical control.
  • Strong knowledge of analytical techniques for biologics or protein-based therapeutics.


For more information Contact Ann Marie Corcoran
 

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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