QA Compliance Officer - Production
About Chanelle Pharma:
This is an opportunity to be part of a dynamic team within the Engineering and Maintenance function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
To proactively lead and deliver the day-to-day Quality Assurance function across Chanelle Pharma’s assigned Production areas (Solid Dose, Liquids, and Packaging). The role will be responsible to deliver on all aspects related to quality compliance and execute tasks such as the creation and execution of quality documents to include but not limited to, change controls, deviations, CAPA, FMEA and customer complaints whilst ensuring compliance to the Quality Management System.
KEY RESPONSIBILITIES:
· To be the overall compliance owner in the assigned production area.
· Report any issues or gaps identified and take the appropriate actions and points of escalation.
· Ensure all quality reports are written and approved within the required timeframe by the department.
· Create, lead & review process investigations and risk assessment documents to ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
· Raise, investigate, and review compliance documents e.g., Change Controls, Deviations, SCARS, Reject Notices, and CAPAs.
· Conduct routine Quality Audits of the department to ensure compliance and be proactive in resolving issues which may arise.
· Be the department point of contact for investigations and all compliance related matters.
· Making sure that all production deviations are reported and evaluated and that critical deviations are investigated in line with SOP/HR/046.2/5.
· Provide and update existing Quality Procedures such as Standard Operating Procedures (SOP’s) in line with GMP regulations.
· Provide compliance training and coaching within the production area.
· Be present on GMP and VM walks and take appropriate actions from these activities.
· Contribute to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
· Support or where necessary lead Quality based projects within the department including working as part of a multidisciplinary team as required.
· Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.
· Support and participate in Change Control meetings and the monthly ‘Quality Management & Review’ meeting.
· Create, update Performance Qualification documents and initiate PQ summary/conclusion reports.
· Any other duties assigned by the responsible Production Manager.
COMPETENCIES:
· Excellent Communication and Interpersonal skills
· Analytical, Methodical, and structured approach to organising their work
· Process Improvement Mindset essential
· Ability to manage multiple critical priorities
· Exceptional Team Playing skills with the ability to manage multiple stakeholders
· Displays flexibility and shows willingness to learn new tasks
· Completes tasks on time, within set time frames and to the highest of standards
QUALIFICATIONS:
· Bachelor’s degree in Quality or Science based discipline
· Lean/Six Sigma, Statistical knowledge is preferred and advantageous in the role
· Minimum of 4-5 years’ experience in a GMP manufacturing environment with working knowledge of EU GMP and US FDA Guidelines essential
· Experience working in pharmaceutical preferred however medical device industry experience will also be considered
· Excellent Report Writing and IT Skills
· Demonstrated hands on experience of delivering a best-in-class QA function in a similar role
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)
· Manual Handling
· VDU
WORK ENVIRONMENT: (e.g., Office, Production)
- Production
- Office
HOURS OF WORK
- 08:30 – 17:00 (Monday – Thursday)
- 08:30 – 16:00 (Friday)
