|Client; Engineering company providing automation solutions from 10+ location globally. It serves chemical, pharmaceutical/biotechnology, automotive, food and beverage, oil/gas, energy, water/wastewater, and other industries. locations in Europe, North America, and Asia. As of August 31, 2014, Process Automation Solutions GmbH operates as a subsidiary of ATS Automation Tooling Systems Inc.
End Client; Pharmaceuticals
Job Title: QA Specialist. Report: Manager QA
Department: QA (QA Manufacturing and Engineering Support Team)
- Acts as the day-to-day QA project contact person for the Manufacturing and Engineering departments providing guidance / feedback on quality issues related to their respective area project activities.
- Completes the review/ approval of Manufacturing and Engineering project documentation – in particular equipment/ process/ automation validation documentation.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Actively contributes to continuous improvement initiatives.
- Builds and maintains good working relationships with Engineering, Manufacturing and
- Quality department personnel in particular.
- Supports the preparation for regulatory and customer GMP inspections of the site in addition to performing and co-ordinating internal audits.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations to ensure they are implemented and accurately documented in a timely manner.
- Participates in developing Standard Operating Procedures (SOP’s) to ensure quality objectives are met.
- Provides guidance and technical knowledge to more junior staff.
- Participates in site cross-departmental teams as the GSIUC QA representative – Attending associated meetings ensuring QA is represented & its concerns/ issues communicated, aiding in the identification of potential improvements and participating in discussions on issues/ queries on the associated systems/process.
- Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
- Ensures compliance with all site safety-related procedures and practices.
- Demonstrates proficient knowledge of FDA/EMA regulations, guidance and current Good Manufacturing Practices (GMPs).
- Experience in the review/ approval of validation documentation essential.
Demonstrates proficiency in MS Office applications (including Word, Excel and Power Point, Adobe, SharePoint) and ability to quickly learn new systems is required.
- Demonstrates the ability to work effectively in a team environment, contributing to a positive and constructive attitude.
- Demonstrates solid verbal, written, and interpersonal communication skills.
Must be able to exercise judgment within generally well-defined and established procedures and practices to determine appropriate action(s).
Demonstrates independent action and initiative in resolving issues.
Demonstrates the ability to prioritise and meet deadlines.
LEAN and Six Sigma philosophy are embedded in your day to day working.
- Minimum of 6 years of relevant experience and a BSc.
- Minimum of 4 years of relevant experience and a MSC.
- Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.