Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

　　We are PCI.

　　Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

　　Main purpose of role:

　　To support the Head of Quality Compliance and Validation and QA director, by managing, hosting and performing client, Regulatory and vendor audits.

　　To ensure the effective administration, monitoring and completion of Quality System activities.

　　The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Head of Quality Compliance and Validation.

　　The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines themselves and by team members.

　　The nature of the role of QMS Manager requires consistency of attitude and behaviour from the job holder to all aspects of Pharmaceutical Quality Assurance and the constant pursuit of excellence and efficiency throughout the organisation.

　　The role demands technical and regulatory knowledge, high standards of attention to detail and the desire to see tasks through to completion.

　　A strong problem solving ability is needed to assist team members in identifying and eliminating problems. Where qualified, the job holder will also be required to train other personnel in quality system procedures and approaches.

　　The job holder must command the respect of peers and co-workers and constantly uphold the company values of trust, integrity, pride, passion, enjoyment and respect in every aspect of their role.

　　Management and Leadership of a team that is responsible to for Vendor Management, Complaints, PQRs, Metrics Compilation, managing the site’s performance on Deviation and Change Controls

　　A high degree of influencing skills will also be required in order to gain the delivery support required from personnel over whom the job holder may have no direct authority.

　　This position has no authority for expenditure.

　　Main responsibilities:

　　The applicant will be responsible for hosting client audits on the PCI, Tredegar Site, both on site and remote client audits.

　　The applicant will be responsible for leading the audit preparation for Regulatory Inspection Audits – developing the inspection plan and ensuring facility readiness.

　　The applicant will complete submission of documents required for provision to the relevant regulatory authorities.

　　The applicant will chair the weekly overdue audit actions meeting, reporting and escalating overdue audit actions in line with an escalation process.

　　The applicant will arrange for Vendor audits and auditors to support the Vendor Management activities.

　　The applicant will co-ordinate audit actions identified from vendor audits, ensuring closure.

　　The applicant may audit external suppliers as required by the business

　　The applicant will manage all the audits through the Achiever system ensuring all actions and activities are captured from Client and Regulatory audits

　　The applicant will be responsible for KPI regarding observations in audit critical, major, minor, etc, reporting into the QMR on a regular basis.

　　Technical/Quality Assurance

　　Daily oversight of team and QMS activities, including: -

　　Adherence to, and reporting of, local and international KPIs

　　Maintain and update the Approved Supplier List.

　　Co-ordinate and complete External Vendor Audits to an agreed program.

　　Co-ordinate and complete annual Product Quality Reviews

　　Conduct Internal Audits to an agreed program.

　　Complete assessments for of suppliers, where necessary.

　　Deputise for Quality Manager where required

　　Track corrective and preventative actions from Internal and External audits. Where possible, close corrective and preventative actions or provide help and advice to other departments to assist with closure.

　　Use PCI software system; Achiever Plus to raise, monitor, implement and close corrective and preventative actions.

　　Schedule audits to comply with PCI procedures, risk assessments and in the most cost effective way.

　　Management and administration of Customer Complaints

　　Report relevant Key Performance Indicators.

　　Conduct GxP training to site personnel and contribute to GxP training packages where necessary.

　　Ensure timely review and approval of relevant Quality documentation.

　　Collation of the company Quality Management Review (QMR) information for review by Senior Management.

　　Proactively seeking opportunities for continuous improvement.

　　Use of Quality Risk Management systems to ensure that risks are adequately controlled in accordance with current requirements.

　　Ensure appropriate investigations of deviations, errors, complaints, failures and adverse events requiring documented review and action.

　　To review non-compliance identified by audit, deviations and complaints and use technical/professional judgement to make appropriate product quality decisions (in association with site QPs) and initiate and promote quality improvements.

　　Technical Administrator and SME for the Achiever Plus system (front end).

　　General/Other duties

　　To identify self-development needs for the future.

　　To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.

　　Work Experience & Skills Required

　　Essential

　　Experience in a similar role in the pharmaceutical industry with up to date credentials relevant to both investigational (clinical trial) and marketed (commercial products).

　　Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups.

　　Proven ability and desire to continuously improve, by seeking new approaches and generating ideas.

　　Proven ability to plan work effectively, by taking a long-term view and developing structured action plans to meet business objectives.

　　Must be able to effectively manage multiple tasks simultaneously.

　　Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail

　　Experience in performing audits, hosting audits and interaction with auditors.

　　Desirable

　　Experience in a Quality Assurance function

　　Experience of Supplier Audits

　　Risk Management Experience

　　Vendor Management experience

　　Qualifications:

　　Equivalent of a BScJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

　　Equal Employment Opportunity (EEO) Statement:

　　PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

　　Why work for PCI Pharma Services?

　　At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

　　PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled