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Salary 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.
The role
The successful candidate will be responsible for ensuring the effective administration, monitoring and completion of quality system activities and for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
The nature of the role 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.
Main responsibilities:
- To manage the supplier management programme.
- Responsible for the administration, monitoring and completion of Nitrosamines statements, coordinating actions between different departments.
- To administrate, monitor and complete the Elemental Impurities Assessments.
- Responsible for the authoring of PQRs.
- The applicant will be responsible for the provision of vendor management metrics.
- Daily oversight of team and QMS activities, including: adherence to, and reporting of, local and international KPIs, maintain and update the Approved Supplier List, coordinate and complete External Vendor Audits to an agreed programme, coordinate and complete annual Product Quality Reviews, conduct Internal Audits to an agreed programme, and complete assessments for of suppliers, where necessary.
- Track corrective and preventative actions from audits. Where possible, close corrective and preventative actions or provide help.
- Use PCI software system to raise, monitor, implement and close corrective and preventative actions.
- Schedule supplier audits to comply with PCI procedures, risk assessments and in the most cost-effective way.
- Management and administration of Customer Complaints.
- 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.
- 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.
- Technical Administrator and SME for the Achiever Plus system (front end).
- Ensure that staff within area of responsibility comply with company Health and Safety Policies and Procedures.
- To manage team performance and absence standards, including coaching, counselling and disciplinary measures as required.
- To conduct performance appraisal and to set targets and objectives for individual members of the group.
- Ensure that all staff appraisals within the area of responsibility are conducted in a timely manner and in line with the approved Human Resources Policy.
- To manage the training requirements within the group to ensure regulatory compliance and business needs are met.
Qualifications:
- Experience in a similar role in the pharmaceutical industry with up-to-date credentials relevant to both investigational and marketed products.
- Experience of auditing (ISO9001, PS9000, EU GMP, 21 CFR, GAMP 5, GDP).
- Knowledge of GMP, GCLP, GDP and GCP regulations and international requirements.
- Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups.
- 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.
- Proven ability and desire to continuously improve, by seeking new approaches and generating ideas.
- Previous experience of the Achiever Plus software system would be advantageous.
- Risk Management Experience would be desirable
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
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.
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.
