Description du poste:
Consider joining (COMPANY NAME), where people are the most important element in our business. (COMPANY NAME) is a leading contract research organisation providing testing and research services in the pharmaceutical and biopharmaceutical sciences to clients worldwide.
We currently have an opportunity for Packaging Technicians to join our PSS Site in Cork
This scope of work involves supporting the client site Packaging team. The individual executing this scope of work will work in close collaboration with the following: Quality, commercial sites and EHS as required.
Primary duties include but are not limited to the following:
* Work as part of a team of Packaging Technicians to complete the packaging of Finished Product for onward distribution.
* Detailed batch record keeping which is accurate, complete, legible & in accordance with cGMP requirements.
* Identify issues on the line and alert the Packaging Equipment Technician. Provide support to the Packaging Equipment Technician to help resolve issues on the line as required.
* Carry out transactions on Oracle as required.
* Ensure the Packaging area is Inspection Ready at all times.
* Participate in regulatory inspections.
* Assist with writing, review and revision of packaging documentation as necessary. (E.g. batch records, standard operating procedures, etc.).
* Demonstrate commitment to a high level of safety awareness within the packaging operations team.
* Proactively support continuous improvement and Lean initiatives within the packaging suite.
* Lead and support the investigation and resolution of process investigations.
* Maintain an exemplary personal training record.
* Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards.
* Participate in cross site teams as required.
* Collaborating with client contacts and working with support and to ensure room and equipment cleanliness, material receipt and control, label and product accountability confirmation, automation set-up and correct functioning, conduct in-process tests and post-operation equipment strip down and clean.
* Develop and apply a working knowledge of relevant electronic system operations, including Oracle, temperature monitoring and product stability information systems.
* Build understanding and follow the clients GMP related quality standards of relevant packaging, label authoring, printing, inspecting and logistics environments.
* Become familiar with understanding the internal and external regulatory environment pertinent to clinical trials and pharmaceutical development and support internal audits and regulatory inspections.
* Foundational understanding in blinding principles and conduct in-process controls to maintain blinding integrity.
* Liaise with Quality groups to ensure appropriate approvals and chain of custody.
* Ensure that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards.
* To learn and be aware of the client's requirements and strive to meet or exceed those requirements keeping in mind the client process end points.
* To learn to deal with client queries and contact designated personnel, with appropriate support from onsite leadership.
* To ensure that the client's requirements are fully met or exceeded and in so doing will be flexible to work in any area of the business as is required.
* To have a clear understanding of the client relationship and service goals.
* To ensure uniformity, reproducibility, and reliability in all work practices.
* To work cohesively in a team environment supporting colleagues collaboratively.
* Once foundational knowledge is in place start to identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.
* To become fully familiar with and keep up to date with any client based processes and regulatory changes, ensuring their training is complete and adjusting their work as required with approval from the Lead Scientist or client.
* To ensure that all documentation is carried out on time, is accurate and legible and conforms to the relevant quality standards.
* To ensure that all decisions are handled with customer service in mind.
* Previous experience of working in a Packaging Technician role within a regulated pharmaceutical environment.
Experience / Skills
* Up to 2 years' relevant experience in a packaging pharmaceutical experience.
* Foundational experience of constructing clinical trial kits and maintaining blinding integrity.
* Good foundational understanding of regulatory processes associated with conducting clinical trials.
* Foundational understanding working in line with GMP supporting the processes and documentation that maintain the license to operate.
* Ability to quickly learn new processes.
* Ability to work using fully electronic media, including MS Office and Oracle.
* Ability to communicate clearly, both written and verbally and to form strong working relationships with colleagues.
* Good attention to detail and time management skills.
* Willing to operate in a flexible manner and able to reuse both internal and external experiences and incorporate them into relevant improvements.
* Ability to switch priorities at short notice is desired.
* Good team player, organised, accurate, have strong documentation skills.
* Good communication skills both internally and externally and avoids making mistakes that will hinder the understanding of written and verbal exchanges.
* Passionate about quality and customer service