Production Technician

OVERALL ROLE OBJECTIVE:

The role of a Production Technician is to provide technical expertise for secondary packaging. The principal function of the role is to ensure the efficient and effective running of technical operations, in accordance with associated protocols & batch documentation whilst maintaining schedule adherence. The Production Technician must also ensure operational compliance with Quality Management Systems (QMS), and adherence to Health and Safety policies.

JOB SPECIFIC RESPONSIBILITIES:

The post holder will be required to conduct a variety of tasks and functions pertaining to their assigned work centre, some of which are listed below;

Qualification/ Validation Support and Routine Production

·         Provide support to Production Operators/ Senior Operators, Supervisors and Technical Staff by assisting in process development, qualification and validation experiments as well as routine GMP operations.

·         Provide support to Production Operators/ Senior Operators, Supervisors and Technical Staff during equipment installation/ operational qualification and validation experiments.

·         Communicate and interact with staff from other departments including Technical Support, Quality Control, Quality Compliance, Technical Quality, Engineering & Facilities to ensure that operations are planned and executed in an efficient manner.

·         Ensure GMP standards are maintained at all stages of manufacture and packaging in line with internal procedures and regulatory requirements. Report any incidents to management that have the potential to impact the quality of the process/ equipment or product.

Technical Subject Matter Expert

·         Operate process equipment according to internal procedures controlling process parameters with limits as defined within SOPs, Protocols and Master Batch Records. As part of this requirement, it may be necessary to instruct and direct work staff (operators, Grade 2 and Grade 3 staff) in the completion of their duties.

·         Where required become the subject matter expert (SME) for specific pieces of equipment or processes, including equipment set-up, optimum operation, strip down and cleaning, product changeover.

·         Develop an awareness of basic maintenance and calibration to enable input to process troubleshooting as well as taking responsibility for monitoring and ordering spare change parts and consumables as necessary.

·         When / where required, liase with equipment manufacturers to resolve issues or improve line efficiency.

Documentation

·         Accurately record and complete techincal information and GMP documentation during production operations associated with pharmaceutical development, manufacturing and packaging operations.

·         Review executed batch records and associated documentation.

·         Support in the generation/ revision of operational procedures/ batch documentation.

·         Support in the generation/ execution of qualification and validation documentation for new equipment and processes.

·         Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) of a given process and report any unexpected observations to senior Formulation, Technical Support or Production personnel. 

Training & Personal Competencies

·         Ensure training has been received before undertaking specific duties and that all training is recorded in training records.

·         Assist with the design and delivery of training material to other Almac personnel for equipment or processes where they are considered to be SME. This will include assessment of competency following such training.

·         Communicate clearly and effectively when processing challenges arise, proactively consider and suggest potential remedial actions.

·         Display a high degree of flexibility in the fulfillment of the role in order to support operational efficiency and any particular client needs.

 

GENERAL ROLE RESPONSIBILITIES:

Quality

Ensure GMP is adhered to in all areas of work.

Almac Pharma Services’ Quality Mission;

To operate within a quality excellence framework that is both efficient and effective and continually assures safe and efficacious product to the patient.

The post holder will, support the quality mission of the business by:

-       Ensuring exceptional and reliable quality in all aspects of work and recognising that quality determines the extent of success.

-       Engaging with the Pharmaceutical Quality System to ensure that quality records are completed accurately and proactively managed in line with committed timelines. Quality performance against set targets is a key goal and aligns with business objectives. 

-       Actively contributing to the Quality Vision outlined by the Senior Management Team of reducing the gap between “where we are today” versus “where we want to be today”.

Health & Safety

Understand Company’s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place.

Training and Development

Ensure training has been received before undertaking specific duties and that all training is recorded in training records.

Human Resource Management

Adhere to all HR policies and procedures, to include all absence policies and procedures.

Communication

Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects.

Equal Opportunities

Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur.

Core Competency Framework

Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework.