Hay line Leader

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 title: Commercial Line Leader - B Shift (JS91)

Accountable to: Business Unit Production Lead (BUPL)

Location: Hay-on-Wye

Hours of work: 40 hours per week - rotating shifts (AM/PM)

We have an exciting opportunity for a Commercial Line Leader on our B shift Production Department, based at Hay on Wye.

Main purpose of role:
Responsibilities include (but are not limited to):
Health and Safety

Ensuring that the requirements of the Health and Safety at Work Act (1974) and where applicable, the Medicines Act (1968) are complied with (e.g. that the Line Leader does not pose a danger to themselves or colleagues and that they comply with cGMP requirements).

The Line Leader will have a thorough understanding of Health and Safety, and is responsible for reporting accidents and near misses correctly. Additionally they will have a thorough knowledge of and be responsible for correct Manual Handling.

COSHH

Ensuring they (and anyone entering the cubicle) are suitably dressed in accordance with the Company dress code and that any protective clothing provided by the Company is correctly worn as directed in the Hazard Data sheet or COSHH assessment sheet

GMP/GCP

Maintaining the immediate work area in a clean, tidy and safe condition at all times. The Line Leader must ensure that they and their team work in a GMP/GCP compliant manner at all times.

Communication

Ability to advise and discuss effectively at all levels. The Line Leader should plan ahead to maintain an efficient flow of work within their cubicle and avoid line stoppages.

Documentation

Is responsible and accountable for the completeness and quality of the production documentation in their cubicle; this also includes any daily recording sheets. The Line Leader will ensure that packaging operations are carried out as instructed and in accordance with the instructions on the Batch Packaging Record or Clinical Trials Methods, and in accordance with any relevant SOPs.

Should a non-conformity occur, then it is the responsibility of the Line Leaders to perform the preliminary investigation and report the details to the Unit Production Lead. The Line Leader will also play a part in implementing the corrective actions to rectify the non-conformity.

Training

Ensure all team members understand and are familiar/working in line with the packaging requirements and current SOPs.

Provide training as required to new team members who enter the cubicle to ensure that they have the skills and knowledge needed to carry out their role. Ensure upkeep of Compliance Wire and training out of SOPs to team members.

Teamwork

Has the lead role in teaching and facilitating working in a team structure. The Line Leader should be self-sufficient, resourceful and have the ability to delegate effectively to others.

Quality Control

The Line Leader is responsible and accountable for the quality of output from their cubicle.

Understand QT role, in process checks (IPCs) and challenges. The Line Leader should be prepared to carry out IPCs and challenges if appropriately trained to do so.

Targets

The Line Leader will assess, perform, communicate and be accountable for the target in their cubicle. They are responsible for maximising output whilst maintaining the quality of product and documentation. They are to monitor the progress and performance of their lines, suggesting improvements and implementing where appropriate. The Line Leader should understand OEE, its system of measurement and KPIs.

Technical Ability

Regarding primary, secondary and tertiary machines, the Line Leader should be able to diagnose and provide guidance to the source of problem. They should understand the importance of checking coding for correctness and legibility.

Changeovers

Prompt and efficient liaison with Quality, Setters and Maintenance to ensure job changeovers and start ups are anticipated correctly and managed efficiently and effectively. Check to ensure all materials, labels and documentation are available for job start.

Shift Handovers

Organise shift handovers with incoming Line Leader. Ensuring all key issues regarding Safety, Quality and Delivery are discussed and actions agreed.

Support Cross-Shift working by ensuring all documentation is handed over to the incoming shift RFT.

Line Layouts

Ability to interpret line layout diagrams, and can set them up. Participate in 5S events and ‘sustain’ cubicle to this standard.

Meetings

Attend all relevant internal meetings (including daily SQDCP) as requested.

Performance Management

The Line Leader will need to carry out return to work interviews and informal discussions in line with the company sickness and disciplinary