Production Technical Operator

Job description

Details:

We are a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing close to 100,000 people globally, we have 87 manufacturing sites around the world.
Our pharmaceuticals business researches, develops and makes available medicines that treat a variety of serious and chronic diseases. We have medicines available or in development in a wide range of areas including:

• infectious diseases
• cancer
• epilepsy
• heart disease
• asthma and chronic obstructive pulmonary disease
• HIV/AIDS

Ware Manufacturing Site:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.

Job Purpose:
The purpose of this role is to either make a blend or take granulated materials, seal into foil strips and pack ready for the patient.

Key responsibilities:
• To set up batches (consisting of input blended granule, foil and packaging materials): booking materials on computer systems, physically bringing the batch materials on line, setting up batch information on printers etc

• Release and print all batch documentation, labels for all batches required to maintain the production schedule. Order all necessary components from the warehouse.

• Perform and check room and equipment cleaning at the end of each batch change, dismantle clean and reassemble. Use appropriate method in the standard operating procedure (SOP).

• Timely and accurate completion of batch record in paperwork form throughout manufacture to comply with good manufacturing processes (GMP).

• To carry out routine In-Process Checks (IPCs) during batch manufacture and where results fall out of specifications escalate to Technician/Shift Coordinator in accordance with SOPs and batch documentation.

• Carry out routine daily and weekly quality checks, verification of balances by following SOPs and sampling of products to ensure both quality compliance and avoidance of cross contamination.

• By following the requirements listed on a batch document, order materials using MERPS (computerised system used to track and record manufacturing activities) and issue to the batch.

• Set, review and adjust machine parameters during start up and running to achieve quality critical targets. Use in process check data to make decisions on adjustment needed i.e. weight control.

• Performing reconciliation using calculations to establish yield and accountable or unaccountable losses.

• Pack Pfos stick packs into cartons using x-ray and cartonning equipment including leaflet or booklet insertion, overprinting with batch details, wrapping and boxing into containers fit for GSK customer sites.

• Identify and assist in the root causing of technical issues eg poor sealing, agreeing corrective actions required to enable the batch to be progressed

• To take on additional roles within the department, as agreed with the individual's manager within the Personal Development Plan (PDP) process. Additional roles in this department include: Author/Content Owner (SOP and/or Standard Work); Quality Management System (QMS) Reviewer; Safety Assessor (Noise, Manual Handling, Ergonomic, Control of Substances Hazardous to Health [COSHH]); Shift Coordinator backup

Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.

Closing date for applications: Friday 9th September

When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:

Ability to read, write and carry out arithmetic to a suitable level to pass OAKs.(issued during application process)

Preferred qualifications:

• Thorough knowledge of operation of multi platform equipment and ancillary equipment (e.g. Toyo filler, packing equipment, PMA25 blender,Radio Frequency (RF) gun) through full on-the-job training programme (typically 28 weeks).
• Ability to follow instructions accurately (SOPs, batch documentation, Trial Protocol Instructions (TPIs), Development Manufacturing Instructions (DMIs), SW).
• Ability to: Release and print all batch paperwork and labels, order all necessary components for the start of each subsequent batch, (e.g. Cartons, Market specific leaflets, Foil), to maintain Fill-Packing production schedule. Small batch runs could require the preparation of several batches for a single line within one shift. Order all necessary consumable materials at the start of each shift to maintain operational running.
• Ability to make quality-critical decisions and take corrective action in the following areas:
1. actions after an IPC failure (bulk weight, weight uniformity, appearance),
2. actions when stick pack attributes are approaching specification limits or falls outside those limits,
3. actions to minimize rejects (including adjustment to the filling machines)
4. monitoring machine data (e.g. control panels and data from manual testing) to maximize output of good strip and therefore batch yields.
• Knowledge of strip-down and reassembly of the stickpack filling & packing equipment to ‘Full Clean' standard and following the procedural cleaning regime: