This is an opportunity to be part of a dynamic team within the production function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
In this role you will report to the Production Manager.
KEY RESPONSIBILITIES:
- Review and Revise Training Documentation.
- Develop and present training programs which support the company training plans.
- Evaluate and implement continuous improvement on design, delivery, and evaluation of training.
- Provide ongoing support to all areas to ensure compliance to the highest GMP standards.
- Perform Annual GMP training.
- Perform/Co-ordinate training on updates to procedure or processes.
- Liaise with Maintenance/Engineering/Quality and design training plans around new equipment/processes/procedures being implemented.
- Update Training Metric and Training Matrix, compile and create the associated reports.
- Assist in preparation of new and review existing procedures.
- Collection and collation of OEE data in the liquids area and the generation of associated reports.
- PlanVisage Liaison, overseeing training and operations regarding to the implementation of PlanVisage in the Liquids area.
- Adherence to health and safety procedures
- Ensure compliance to documented procedures and GMP requirements as outlined in company procedures.
- Maintenance of hygiene / housekeeping standards in the production area
- Comply to terms and conditions outlined in your contract of employment
- Generate reports as requested
- Identify corrective actions
- Liaise with Quality
- Review Batch Paperwork and carry out the necessary completions on Perito System, update the End of Line File & Shipping Schedule.
- Initiation, completion and closing of Deviations, CCF’s and CAPA’s
- Assist in the smooth running of Plan Visage.
- Update all logs as requested by production, planning and quality.
- Binding books for Downtime and Cleaning Books for Production Area.
- Organise efficient line clearances, review cleaning logs and sign accordingly.
- Manufacture / pack product to GMP / FDA and regulatory standards as outlined in company documentation
- Accurate completion of all necessary documentation, and review of work orders prior to sign off.
- Carry out IPC checks as outlined in company documentation.
- Clean machines / work area in accordance with standard operating procedures.
- Perform regular GMP walks of the production rooms
- The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
COMPETENCIES:
- Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
- Ability to train a team and manage diverse personalities and viewpoints.
- Ability to build relationships and collaborate with others is vital.
- Strategic decision-making within the business as an influencer.
- Demonstrate and lead on the values, initiatives, and culture of an organization. Professional expertise.
- A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
- Demonstrated ability in prioritizing key initiatives, driving growth and setting targets
- Practical, action-orientated approach to managing priorities and teams.
- Possesses knowledge of lean management principles and has a keen interest in the benefits of lean management systems and principles to the manufacturing process.
- Possesses the required job skills and knowledge and effectively applies them to work assignments, willingly mentors staff and shares knowledge, seeks/applies innovative and relevant techniques.
- Communicates in clear, effective, timely, concise, and organized manner, is articulate and persuasive in presenting, soliciting complex or sensitive data
- Requires minimal supervision, consistently promotes, and maintains a harmonious/productive work environment
- Strong computer skills in MS office, Operating systems, and a wide variety of software suites.
- Practical thinker who enjoys problem solving and solution development.
QUALIFICATIONS:
- Experience working within a pharmaceutical Environment; with knowledge of EU, GMP and US FDA Guidelines
- Train the Trainer certified Trainer
- Excellent written and verbal communication skills
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)
WORK ENVIRONMENT: (e.g. Office, Production)
Chanelle Pharma
Dublin Road, Loughrea,
Co Galway, Ireland.