Job Description

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.

Purpose:

The purpose of the Senior Production Associate - Packaging and Labelling is to provide support to Packaging and Labelling operations at PCI. This will incorporate proactively ensuring readiness to commence Packaging and Labelling activities – ensuring that the production facility/rooms, equipment and resources are available and ready, checking production materials are available and have been staged, and batch records are available for Packaging and Labelling activity to start.

The role will work with Production Associates, Project Managers and Warehouse to ensure appropriate materials, consumables, rooms, equipment and labels are available for the proposed production activities and ensuring that the resources are allocated according to the Production Schedule.

The Senior Production Associate - Packaging and Labelling will participate in document reviews, including Master Batch Records, Logbooks and SOPs, confirming that these are appropriate for introduction and use in the production facility. The role will also incorporate the review of executed batch records and staff training that is required upfront, or as a result of CAPA completion.

The Senior Production Associate - Packaging and Labelling will assist 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.

The Senior Production Associate - Packaging and Labelling will highlight and execute opportunities for efficiency, organisation and good housekeeping within the department. The Senior Production Associate - Packaging and Labelling will also champion safety adherence within the department and will assist with closeout of safety actions.

General description:

The Senior Production Associate - Packaging and Labelling has responsibility for ensuring that Packaging and labelling production can commence as scheduled.

The Senior Production Associate - Packaging and Labelling has responsibility for ensuring that the required documentation has been reviewed and is available for production to start.

The Senior Production Associate - Packaging and Labelling has responsibility for checking that the materials and equipment have been staged and checked.

The Senior Production Associate - Packaging and Labelling will ensure that PPEs, gowning etc. are available and received in the production facility accordingly.

The Senior Production Associate - Packaging and Labelling also assist in the maintenance of the cGMP facility licence and may be required to assist in facility audits (e.g. PCI internal audits, and audits conducted by Clients/Sponsors, and Regulatory Authority Inspections).

SECTION SIX Primary Responsibilities & Duties (key tasks & responsibilities)

The primary responsibilities of this position are:

Primary responsibility for supporting the operational activities of the packaging and labelling facility. Other duties include:

• 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.

SECTION SEVEN Qualifications, Experience & Behavioural Competencies

The 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

The desired qualifications & experience:

• Scientific experience

• Previous industry manufacturing experience

The 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.