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.
Position Overview:
The purpose of the Senior Production Associate - Packaging and Labelling is to provide support to Packaging and Labelling operations at PCI.
This incorporates proactively ensuring readiness to commence Packaging and Labelling activities; production facility/rooms, equipment and resources are available and ready, checking production materials availability and have been staged, and batch records are available for Packaging and Labelling activity to start.
The role works with and alongside Production Associates, Project Managers and Warehouse Associates to ensure appropriate materials, consumables, rooms, equipment and labels are available for production activities and ensures resources are allocated according to the Production Schedule.
The Senior Production Associate - Packaging and Labelling also:
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participates in document reviews, including Master Batch Records, Logbooks and SOPs and training required upfront, or as a result of CAPA completion;
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assists in the introduction of new equipment into the facility including ensuring SOPs are prepared, qualification/validation is complete, equipment logbooks are prepared and available, equipment and rooms are appropriately cleaned and maintained;
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highlights and actions opportunities for efficiency, organisation and good housekeeping within the department;
- champions safety adherence within the department and assists with closing out safety actions;
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ensures that PPEs, gowning etc. are available and received in the production facility accordingly; and
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assists in the maintenance of the cGMP facility licence and may assist in facility audits (e.g. PCI internal audits, and audits conducted by Clients/Sponsors, and Regulatory Authority Inspections).
Primary Responsibilities of this Position are:
This position's primary responsibility is to support the operational activities of the Packaging and Labelling facility specifically involving:
Completing company training requirements in accordance with curricula and other training as may be required (e.g. completion of training when SOPs are updated or new SOPs issued that are applicable to production).
Ensure that the Master Batch Record is reviewed, the required batch record has been approved, and Quality issued prior to use and verify that the data, and information are correct, unambiguous, and clear for Production to run the batch.
Ensuring that released or stock is in “I” status and correct equipment is picked for production in accordance with the batch record prior to the commencement of production activity.
Organise workflow by ensuring required consumables, materials and equipment have been staged in time and staff assigned.
Maintains a clean and safe environment.
Enforce strict safety guidelines and company standards.
Assist with the on the job / competency training of new and existing Production Associates.
Reviewing executed production batch records and ensuring that these are completed and signed prior to forwarding to Quality for review and release.
Ensure all relevant transactions have been updated in the ERP system
Preparation and review of documentation as required including MBRs, SOPs, qualification/validation protocols, URS etc.
Participating in PCI internal audits and third-party audits and assist in responding to audit findings and product complaints/recalls as may be required
Assisting Clinical Projects and Customer Experience Team as required in preparing and reviewing MBRs, BRs, etc. prior to approval.
Assisting Storage and Distribution, Projects and Quality departments as required.
Assist in the capture of data and metrics of production processes and report them as required.
Raise EVENTS in MasterControl when issues are identified during Packaging & Labelling activity affecting product quality and patient safety.
Assist Production Associate Manager for investigation arising due to EVENT/DEV/NONC/COMP that occurs during production activity.
Review/perform checks as required during production activity and provides assistance and support to Production Associates to ensure right first time on batches and product quality.
Other duties as required by Manager/Head of Production.
Mandatory Qualifications & Experience:
Previous industry experience and/or Bachelor of Science, Pharmacy or related Discipline
Excellent written and verbal skills with good attention to detail
Documented cGMP training
Previous industry manufacturing and/or science experience
Behavioural Competencies required for this Position:
High level of professionalism, ethics, quality of work, communication and responsiveness at all times
Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values
Analytical thinker and solution finder/problem solver
Collaborative Leader and team player
Objective and robust decision maker
Self-confident and self-respectful
Excellent interpersonal, written and verbal communication
Self-motivated, achievement and outcomes orientated
Trusting and trustworthy
Conscientious and diligent
Other duties as required by Manager/Head of Production.
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.
At PCI, Equity and Inclusion 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.
