i-Pharm Consulting

Sr Quality Assurance Specialist

Location
Dún Laoghaire
Salary
60,000 - 80,000
Posted
02 Jan 2019
Closes
16 Jan 2019
Ref
BT055
Discipline
Quality, QA / QC
Contract Type
Contract
JOB TITLE
Senior Quality Assurance Specialist – 12+ month contract

THE COMPANY

One of the top Biopharmaceutical companies in the world. The organisation is seeking a talented individual with 5+ years experience in a similar role. This is an excellent opportunity for someone looking to progress their career in a global company.

LOCATION

Dun Laoghaire, Ireland

SALARY
Up to €375 Per Day

ROLE/DESCRIPTION

* Perform all activities in compliance with Amgen safety standards and SOPs
* Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
* Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
* Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
* Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
* Participates in customer complaint investigations.
* Provides training and advice to staff in order for them to perform their desired functions.

QA Technical Support and Disposition Function (may perform some or all of these duties)

* Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations.
* Act as Quality point of contact and decision maker during Technology Transfer and Process Validation activities whilst ensuring that all activities meet internal and regulatory expectations.
* Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review.
* Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
* Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.
* Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.

EXPERIENCE NEEDED

* University degree. Engineering or Science related discipline preferred.
* Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

DESIRED

* Experience working with dynamic cross-functional teams and proven abilities in decision making
* Demonstrated ability in managing Root Cause Analysis / NCs /Deviations
* Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
* Experience working in aseptic operations, protein formulation, vial and syringe filling.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY:
If you would like to discuss this vacancy further, please call the Global Strategic Delivery Consultant Billy Twomey on +44 (0)2031890460. If this role is not suitable, Billy is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
Quality Assurance / QA / Quality Assurance Specialist / Biopharmaceutical / Dun Laoghaire / Contract / Pharmaceuticals / Pharma / Ireland /

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