Cork: +353 21 4509200 | Dublin: +353 1 5175910
jobs my account call
Search Jobs
Advanced
to

Senior Quality Specialist

Quality & Laboratory
Cork
Siobhán Lane
Temporary
Favourites Share with a friend
Job Reference: JO-2005-65183_1589280196

Summary:


Responsibilities:


* Performs a wide variety of activities in the role of QA specialist to ensure compliance with applicable regulatory requirements through support of the site Serialisation system upgrade.


* Maintains programs and processes to ensure compliance with current Good Manufacturing Practices (GMPs).


* Quality review and contribution to change management procedure(s) of the project.


* Quality review and contribution to lifecycle validation documentation: IQ, OQ, PQ in conjunction with other project team members (SME, System Owner, Business Owner and Validation).


* Quality review and contribution to risk assessments (Process and Electronic).


* Precipitate and contribute to project design reviews, team meetings and process development.


* Performs activities to ensure compliance with applicable regulatory requirements.


* Participates in developing Standard Operating Procedures to ensure quality objectives are met.


* Maintains processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).


* Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.


* This is an advanced position requiring significant expertise/specialization in area of work.


* Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.


* Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.


* May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to packaged products.


* Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and manufacturing.


* Works directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.


* May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.


* May assist with compliance audits as required.


* Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.


* Normally receives no instruction on routine work, general instructions on new assignments.



Requirements:


* 6+ years of relevant experience in a GMP environment related field and a BS or BA.


* 4+ years of relevant experience and a MS.


* Demonstrates proficiency in Good Manufacturing Practices (GMPs).


* Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and engineering requirements.


* Previous experience with Change Management, Validation and Commissioning Documentation requirements is highly desirable


* Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like packaging and engineering.


* Demonstrates strong knowledge of Six Sigma, Lean and root cause analysis tools used for identifying and correcting deviations.


* Ability to deliver in a challenging environment


* System and IT knowledge.


* Serialisation Knowledge




Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


Fastnet - The Talent Group
'Not Just Placers.........Partners'


The Life Science Specialists


View more Jobs in Quality & Laboratory
Share this job with a friend:
Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
Ask a question about this job
More jobs from Siobhán Lane >
View more Jobs in Quality & Laboratory
Share this job with a friend:
Website Design by Dmac Media