Senior QA Specialist

Republic of Ireland  ‐ Onsite
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Description

General QA Specialist Responsibilities:

* Provide training and advice to staff in order for them to perform their desired functions.

* Perform all activities in compliance with safety standards and SOPs

* Provide Quality direction and input at Change Control and Review Boards and assume oversight of change control and 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 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 CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable

* 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.
Basic Qualifications:

* University degree - Engineering or Science related discipline preferred.

* Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications:

* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations

* Detailed Knowledge of applicable Regulatory requirements . Experience with Regulatory inspections.

If you would like to apply please contact Sarah Irvine on or reply with a copy of your most current CV. We also offer shopping vouchers for any successful referrals so if you know of anyone who may be suitable feel free to get in touch.
Start date
09/2015
From
Real Staffing
Published at
28.08.2015
Project ID:
974623
Contract type
Freelance
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