Production Supervisor

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.

This Position reports to the Head of Production and is based at our Moorabbin site. The key purpose of the Production Supervisor is to oversee labelling and secondary packaging of finished product manufactured by PCI or supplied by clients. This incorporates allocation of appropriate production employees and facilities/rooms in consultation with Project Managers as well as allocation of Label Compliance Associates to ensure labels have been approved by clients and printed ready for Production activities.

This position encompasses the following:

- day to day operational activities of the packaging facilities, rostering employees and scheduling of labelling and secondary packaging activities within PCI’s production and packaging facilities;
- working closely with Project Managers, Production and Label Compliance employees to ensure appropriate materials, consumables, equipment and labels are available for proposed production activities;
- in addition to rostering employees, assisting identification and selection of new employees based on projected labelling and secondary packaging requirements and ensures ongoing training is conducted and participates in employee performance management;
- packaging facility maintenance in accordance with GMP principles and PCI procedures including confirming maintenance of the facility demonstrated through the completion of facility, equipment and cleaning logs and liaising with Facilities and Engineering and Quality to ensure 3rd party facility qualification tasks are complete;
- participating in document reviews, including Master Batch Records, Specifications and SOPs, confirming these are appropriate for introduction and use in the facility and during batch execution ensuring production employees complete documentation in accordance with SOPs and cGMP principles;
- assisting with the introduction of new equipment into the facility including SOPs, qualification/validation is complete and equipment is appropriately cleaned and maintained;
- ensuring deviations and CAPAs are completed in a timely manner in accordance with due dates as well as compliance to training requirements and department KPIs; and
- as part of the supervisory team, participate in Project Management and client meetings and in the preparation and participation of various audits (client audits and regulatory authority inspections).

In summary, primary responsibilities & duties (key responsibilities & tasks) include:

- Rostering employees and scheduling of labelling and secondary packaging activities within the facilities
- Review of EBRs following production completion to ensure good documentation practices are adhered to and any issues are identified and resolved before batch release
- Production employee training and performance management
- Facility maintenance in line with PCI SOPs
- Preparation and review of documentation as required including MBRs, SOPs, IQOQs, URS
- Participation in Project Management, Client and Audit meetings as required
- 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)
- Ensuring production employees complete company training requirements in accordance with curricula and other training as may be required
- Ensuring the required Batch Record has been approved and QA issued prior to use
- Ensuring that all deviations are raised, reported and investigated and CAPAs followed through to completion.

Mandatory Qualifications & Experience:

- Previous industry experience in Pharma production facility in a Supervisory/Management position
- Documented cGMP Training
- Excellent written and verbal skills with good attention to detail
- Bachelor of Pharma (preferred), Science, Engineering or equivalent
- Project Management experience (preferred)

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
- Effective stakeholder, team and time management skills
- Trusting and trustworthy
- Conscientious and diligent
- Positively embraces and is responsive to change

Join us and be part of building the bridge between life changing therapies and patients.

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