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 the role:To provide assurance of the quality of the packaging process by performing online and final Batch Record review, clearance verification, quality checks for label printing operations, investigation and deviation reporting, to provide support and advice to the production group.
Main Responsibilities:Clearance Verification of packing lines before materials are introduced to ensure free from materials from a previous operation and the equipment has been cleaned as per the relevant SOP.Perform online Batch Record reviews during packaging of Commercial and Clinical work orders.
Identify right first time documentation issues in real time, discuss and resolve issues with Production and Engineering teams.Review of Commercial and Clinical Batch Documentation prior to QP release, including completion of paperwork, resolution of deficiencies and inaccuracies, reconciliation, preparation of release documentation, work actively with the production team to resolve any issues which have been identified.Assist with generation of EU release documentation (ie Batch release certificates).Assist in and decision making relating to operational quality issues.Complete minor complaint investigations, identify root cause and robust CAPAs to eradicate reoccurrence of issue.Assist with initiating any nonconforming events within the QMS.
Advice senior Quality personnel of any deviation / non-conformance / abnormality observed with finished product.Provide advice on quality related issues during new product introductions.Support the Quality Assurance team with review and approval of pre-batch documentation prior to issuing to production teams.Support with issuing additional batch documentation requested during packaging.Perform handover with incoming shift ensuring effective communication of any shift issues and workload status.Lead or be part of team in Continuous Improvement activities.Checking of clinical trial and commercial labels for accuracy.Assistance in other paperwork related functions within the department as required.Record right first time issues within PCI RFT database.Design and maintenance of Quality related documentation to include SOPs and Standard Documents as appropriate and as agreed with operations department.Ensure compliance of company's activities with the requirements of the EU Guidance on Good Manufacturing Practice by maintaining high standards of cGMP (EU and US CFRs) and ensuring that customer expectations are met.Ensuring that the requirements of the Health and Safety at Work Act and where applicable the Medicines Act, are complied with i.e.
that the operator does not pose a danger to him/herself or colleagues, and that GMP instructions are complied with.Take care of your own health and safety and that of people who may be affected by what you do (or do not do).
Co-operate with others on health and safety, and not interfere with, or misuse, anything provided for your health, safety or welfare.Any other reasonable duty.Work Experience / Skills Required:Relevant experience within GMP or similar environmentExperience of working to quality standardsKnowledge of quality related procedures and documentationUnderstanding of GMP and the Quality Assurance role within GMPAbility to train and develop othersGood IT skills (Microsoft Office)Ability to identify and solve problemsDecision making skillsAbility to work unsupervised, work as part of a team and aloneAbility to influence othersGood administrative & organisational skillsQuality focused, with a high level of care and attention to detailGood interpersonal skillsCompetent in written and verbal communicationProactiveApproachableTeam playerConscientiousExcellent attention to detailResponsibleAbility to prioritise tasks and work to deadlinesLogicalFlexibility within working patternsQualifications:Maths and English minimum GCSE A* - C or equivalent
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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. At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies.
We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level.
We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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