Senior Quality Assurance Supplier Specialist - Biopharma

Competitive
Permanent
Limerick
14 May 2020
BBBH759460

Excellent opportunity to join a state of the art Bulk Biologics facility in Limerick

I am currently working with a leading biotechnology company that invents life-transforming medicines for people with serious diseases. This company are going through huge expansion at the moment and are on the lookout for a Senior Quality Assurance Supplier Specialist (Raw Materials) to join their team on a Permanent basis.

This company will give you brilliant exposure to a fast paced, full on facility where the growth potential and promotional opportunities are well within your grasp. This is an excellent opportunity for anyone who loves to be kept busy and are highly career focused.

This position is an integral part of the company's program to assure that raw materials used in manufacturing are of the appropriate quality to facilitate the production of drug product. It requires working with the company's cross-functional teams and suppliers to resolve quality issues and assure product quality

In summary, the role oversees the management of raw materials and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs and SOPs

Responsibilities include:

  • Reviews release data, prepares appropriate release documentation and executes release of vendor raw materials.
  • Performs AQL visual inspections.
  • Manages QA requirements of SCAR process i.e. initiation, review, approval, monitoring
  • Support Supplier Quality Group as needed
  • Support Warehouse & Logistics Group as needed
  • Initiates, edits, review and approves change control and SOPs.
  • Provide training as required within the QA Raw Materials Group
  • Performs compliance monitoring of area operations and notifies area and Quality Management of any observed non-compliance.
  • Participates in regulatory and customer audits
  • Identify gaps in systems and develop feasible plans for correction
  • Training of personnel on quality system processes
  • Manages direct reports where required

Education and Experience:

  • Requires BS/BA in scientific discipline or related field plus minimum 6 years of relevant experience.
  • Minimum 2 years supervisory experience preferable.

If this sounds of interest, or if you would like to hear more then click the 'Apply Now' button below or reach out to Kellie on kodonovan@morganmckinley.com or 021 2300 300.

Other live vacancies:

  • Validation Specialist - Permanent - Pharma - Cork
  • Quality Specialist - Permanent - Pharma - Cork
  • Quality Supervisor - Permanent - Essential Oils - Cork
  • Quality Systems Associate - Permanent - Biopharma - Cork

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Kellie O'Donovan's picture
Consultant | Engineering Recruitment - Quality & Validation
Cork 353 (0) 21 2300300 | kodonovan@morganmckinley.com