QA Specialist supporting an IT project with the upgrade of the site Serialisation System (12 months). This is a contract role and this position requires experience and expertise in the support of an IT project with the upgrade of the site Serialisation System acting as the lead QA rep on the project.
The role will involve providing Quality guidance on the project and ensuring the system is delivered in compliance with the company’s governing quality procedures including review and sign off of associated validation documentation from a quality perspective.
The successful candidate will be required to work on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. The candidate will be required to exercise judgement to determine appropriate action with minimal supervision. The candidate will need to have demonstrated proficiency in the application of QA principles, concepts, industry practices and standards with specific emphasis on packaging, engineering and validation requirements.
- 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 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 the 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.
Knowledge and Skills:
- Demonstrates proficiency in Good Manufacturing Practices (GMPs).
- Demonstrates proficiency in the 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.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, technical writing and interpersonal skills.
- Demonstrates proficiency in Microsoft Office applications.
- Ability to deliver in a challenging environment
- System and IT knowledge.
- Serialisation Knowledge.
Typical Education and Experience:
- 6+ years of relevant experience in a GMP environment related field and a BS or BA.
- 4+ years of relevant experience and a MS.
- Prior experience in the pharmaceutical industry is preferred.
12-month Fixed Term Contract
For a confidential discussion on this or any other current opportunity please contact Nicola Murphy on 021 233 9200 / [email protected]
Please note that your application for this vacancy will be forwarded to all the consultants in The Logiskills Group as you may be suitable for other roles that we are unable to advertise.
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