Senior Operator Grade 2 (Continental Day shift) - Pharma Services

The post holder will:

1. Ensure processes and procedures are complied with in order to produce product within acceptable limits & regulatory standards:

Before each batch commences, ensure that the production room to be used has been cleaned and cleared after the last operation as per appropriate SOPs.

Ensure that the correct input material has been issued and received into the production operation, ensuring all batch documentation received into the department is appropriate, in full and correct and that batch records are being reviewed and completed "live" within the room, during the operation.

Set up the production equipment to produce the product required.

Ensure that all set up checks and challenges are performed as required during the production operation.

Operate various pieces of equipment and process within the production areas as instructed by an authorised Grade 3

At the completion of an operation, verify the reconciliation of all materials used in the operation and ensure that all samples etc. are collected before the completed batch and all unused items are returned to the warehouse.

Organise room layout to ensure that the product is manufactured in an efficient manner. Ensure process optimisation and downtime reduction, with downtime tracked through the variance tracker and corrective actions put in place at all times

Fully understand and adhere to instructions as detailed in the batch documentation and SOPs.

Complete all documentation in a tidy and accurate manner. This includes Works Orders, Validation Protocols, Room and Equipment Log Books, In Process Check sheets (IPCs) and Acceptable Quality Level sheets (AQLs).

Ensure that your operation achieves the output as detailed on the production schedule and that any anomalies are reported to the Grade 3.

Clean equipment and packaging areas required for production

1. Effectively oversee staff within designated operations:

Ensure staff are conducting operations in line with company and client requirements, whilst compliant with all company policies and practices, including H&S, Environmental and GMP.

Convey appropriate instructions and information about the operation to all team members (if applicable).

Ensure operators’ are trained and competent in the tasks they are performing and queries or concerns raised are addressed at the earliest opportunity, with the escalation of any further matters in a timely manner to the Grade 3.

Undertake any other duties or instructions as required by the Production Supervisor.

1. Ensure GMP & Quality standards are maintained:

Undertake all processing operations in compliance with GMP, batch documentation and SOPs

Operate required equipment to produce the full batch in compliance with GMP, batch documentation and SOPs

Organise and manage team members to ensure compliance with GMP, batch documentation, SOPs and the company’s H&S and Environmental policies and practices as required.

Report any compliance and quality concerns, breaches of procedure or examples of substandard quality to the Grade 3, Production Supervisor or Manager

During periods of high volume work requests this role will require additional coverage beyond normal working. It is a condition of your employment that you are able to fulfil this requirement of the role.

To control the process operation (staff and/or equipment) within the designated production room while assuring that the quality of the product produced complies with GMP. The ability to work various shift patterns, will be essential., 4 GCSEs (or equivalent) at Grade C or above (including English Language and Maths)

Experience in a production environment involving production teams, machinery, and quality control of product

Experience of working within teams, demonstrating leadership capabilities.

Ability to demonstrate competency throughout manufacturing and packaging operations

Excellent communication skills (verbal and written)

Effective leadership skills

Ability to complete documentation to a high standard

Proven ability to work effectively on own initiative and effectively contribute within a team environment.

DESIRABLE REQUIREMENT

Experience in set up, operation and clean down of process equipment an advantage.

Experience of leading teams (supervisory experience).