Packaging Senior Operator

Job description

Job responsibilities

Communication and working relationships

Ensuring that the requirements of the Health & Safety at Work Act 1974, and where applicable the Medicines Act 1968 are complied with (e.g. that the Packaging Operator does not pose a danger to themselves or work colleagues and that all cGMP instructions are complied with)

To complete all documentation in a clear, precise, contemporaneous and legible manner in accordance with Data Integrity principles

To inform the Production & Packaging Manager, Packaging Specialist, Packaging Team Leader or any member of the engineering team of anything concerning any defect or issue with a product, equipment, facilities, components, documentation and to check equipment is fit for purpose before any packaging activities commence

To understand the QC role, in process checks (IPCs) and challenges. The senior production operator may be asked to carry out IPCs and equipment challenges if appropriately trained to do so

Actively participate in internal and external audits, to act as relevant expert during external audits

Communicate effectively with packaging team members, senior staff, other departments and regulatory auditors

To be part of small specialist teams, creating strong team spirit environments, valuing the contribution of others and forming co-operative working relationships with colleagues

To develop effective interpersonal skills for the delivery of training, recognising barriers to communication and the most appropriate means of delivery depending on the individuals and activities involved

To participate in 5S and sustain the packaging areas to this standard, to participate in KPI meetings

Attend all relevant internal and Packaging team meetings as requested. Attend and contribute to daily Packaging meetings, responsibility for providing line metric data, KPI measurement data and briefings to staff

The post holder reports to their Packaging Team Leader

The post holder is in regular contact with all Torbay Pharmaceuticals operational and management personnel

The post holder will interface with regulatory and customer auditors when necessary

Planning and organisation

Demonstrate the ability to multitask when required and respond to a variable workload with unexpected interruptions with changed deadlines. To manage aggressive customer deadlines in relation to on-time/in full product delivery

Responsible as part of a specialist team for inspection, labelling, packing and serialising of products in compliance with all manufacturing SOPs, Batch Documentation, H&S requirements and cGMP

Responsibility and accountability

Policy and service responsibility

Responsible for ensuring that the Packaging facility and pharmaceutical processing equipment are maintained to the standard of cleanliness and sterility required of Torbay Pharmaceuticals and regulatory guidelines and standards (Pharmaceutical cGMP)

To read and understand all applicable SOPs, to understand the importance of all activities and processes. To understand the importance of the pharmaceutical products being manufactured

To work both as an individual and as part of a team, to support operational efficiency and continuous improvement programmes and to ensure that at all times all activities comply with Good Manufacturing Practice, the units ISO accreditations and other relevant guidelines; H&S guidelines, procedures and practices

Responsibility for finance, equipment and other resources

Responsible for basic fault finding and once this process is exhausted responsible for escalating production issues to the Packaging Team Leader, Packaging Specialist or Production & Packaging Manager. Expectation is that basic fault finding will be investigated to root cause and solution and all associated documentation managed

To actively contribute and lead areas of continuous improvement

Requires the frequent movement of items weighing up to 15kg without the use of mechanical aids in accordance with H&S regulations. Requires frequent movement of loaded pallets and product trolleys

Occasional handling of hazardous chemicals and cleaning chemicals requiring the use of personal protective equipment and clothing

Responsibility for supervision, leadership and management

• Responsible for supervising small specialist teams of operators
• Ensuring that they are suitably dressed in accordance with Company dress code and that any personal protective clothing provided is correctly worn as directed by SOPs, Hazard Data Sheet or COSHH Assessment sheets
• All staff must be regularly assessed on their knowledge, skills and behaviour in line with the Trusts Achievement Review (AR). The post holder will make themselves familiar with and abide by Trust policies and procedures

Information technology and administrative duties

• To enter accurately any data required on batch documentation, complete necessary documentation and to take signatory responsibility for key events where suitably trained and authorised to do so
• The Packaging Senior Operator is responsible and accountable for the quality of the task or process that they are performing; they are responsible on completion of satisfactory training for the set-up, entry of data to computerised systems and operation of complex equipment. The Packaging Senior Operator is also responsible for the second checking of these processes
• To assist and take appropriate action in the investigation of corrective action and deviation documents. To accurately enter production details in Q-Pulse (Electronic Quality Management System) and complete directed actions as required
• To participate in validation studies, collect technical data, read/understand and assess technical manuals

Person Specification

Qualifications & Skills

Essential

• GCSE Maths & English or equivalent
• Basic IT Training

Desirable

• Management or leadership skills

Knowledge

Essential

• Moving and Manual Handling knowledge
• H&S understanding
• Knowledge of Quality Management systems

Desirable

• Knowledge of Home Office Controlled drug requirements.
• Knowledge of Good Manufacturing Practice (GMP)
• Understanding of the Principles of Lean

Experience

Essential

• Experience of working with machinery in a previous role
• Working with Standard Operating Procedures (SOP) and Work Instructions
• Previous experience in a Quality-focused role

Desirable

• Experience of fault-finding and resolving issues on machinery
• Experience of working with ERP system/s
• Experience of leading a team
• Experience and a detailed understanding of the regulatory standards related to manufacturing and associated procedures.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Torbay and South Devon NHS Foundation Trust

Address

Torbay Pharmaceuticals

Wilkins Drive

Paignton

TQ4 7FG

Employer's website

https://www.torbayandsouthdevon.nhs.uk (Opens in a new tab)