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Associate QA Specialist - Batch Release

Title : Associate QA Specialist - Batch Release profile
Sector : Scientific & Laboratory
Location : Limerick
Reference : CW121927
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

ASSOCIATE QA SPECIALIST - BATCH RELEASE required by CareerWise Recruitment for our BioTech client in Limerick. The ASSOCIATE QA SPECIALIST - BATCH RELEASE will be responsible for preparation & review of batch disposition documentation to support QP release of Formulated Drug Substance.

Role of this position

  • Review of QC related release data.
  • Documentation review.
  • Compilation of deviation, change control & batch record reports to support disposition.
  • Perform status labeling of product as required.
  • Represent Quality Assurance in support of deviations, CAPAs, etc., as required.
  • Provides consultation or advice in alignment with QA policies.
  • Review, edit, or approve controlled documents.
  • Interacts with various departments to ensure batch release deliverables are met.

JOB REQUIREMENTS

  • Understanding of biologics manufacturing operations is preferred.
  • Excellent organizational skills and attention to detail essential.
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to learn and utilize computerized systems for daily performance of tasks.
  • Ability to prioritize, manage multiple tasks, and meet deadlines.
  • Requires BS/BA in scientific discipline or related field and minimum 2 year relevant experience.
  • Relevant experience may be substituted for education requirement.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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Careerwise Recruitment



Associate QA Specialist - Batch Release

Title : Associate QA Specialist - Batch Release profile
Sector : Scientific & Laboratory
Location : Limerick
Reference : CW121927
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

ASSOCIATE QA SPECIALIST - BATCH RELEASE required by CareerWise Recruitment for our BioTech client in Limerick. The ASSOCIATE QA SPECIALIST - BATCH RELEASE will be responsible for preparation & review of batch disposition documentation to support QP release of Formulated Drug Substance.

Role of this position

  • Review of QC related release data.
  • Documentation review.
  • Compilation of deviation, change control & batch record reports to support disposition.
  • Perform status labeling of product as required.
  • Represent Quality Assurance in support of deviations, CAPAs, etc., as required.
  • Provides consultation or advice in alignment with QA policies.
  • Review, edit, or approve controlled documents.
  • Interacts with various departments to ensure batch release deliverables are met.

JOB REQUIREMENTS

  • Understanding of biologics manufacturing operations is preferred.
  • Excellent organizational skills and attention to detail essential.
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to learn and utilize computerized systems for daily performance of tasks.
  • Ability to prioritize, manage multiple tasks, and meet deadlines.
  • Requires BS/BA in scientific discipline or related field and minimum 2 year relevant experience.
  • Relevant experience may be substituted for education requirement.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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