LD Systems & Compliance Specialist

Dunboyne - Ireland

Monthly Salary: Not Disclosed

Experience Required: 4-5years

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

About PSC Biotech

Who are we

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Overview:

Responsible for the design facilitation implementation and optimization of site Training system learning programs and training initiatives for the site. Ensure that objectives are effectively achieved consistent with requirements to ensure compliance safety and reliable supply to our customers.

Requirements

Key Accountabilities

Assess and prioritise training needs for the site (e.g. through consultation with L&D Lead Global L&D Contact managers/ system owners and subject matter experts) with reference to the sites strategic goals.
Support managers and individuals by providing information advice and resources in order to promote a high performing organisation. This includes design and delivery of customized training plans for new and existing
employees.
LMS System admin/ super user: Lead the day-to-day operation of the learning management system in compliance with site procedures.
Provide guidance for the design of training programs and assist in evaluation of training activities.
Develop training content including materials and/or training aids required to deliver training programs.
Act as Sub System Owner (Business Process Owner) delegate (Chapter 3.1 Training and Qualification) and provide audit support for training system as required. Act as subject matter expert for the training system.
Work with relevant departments to prepare the Annual GMP and EHS training plans for the site
Participate in conducting training audits across the site ensuring the site is audit/inspection ready in relation to all training requirements and be the training point of contact for internally and externally audits.
Implement and ensure adherence to the site learning processes and foster a continuous learning environment.
Maintain and continuously improve standard site learning processes (i.e. Job Skills Qualification SOP Process
Annual GMP Safety Programs and New Employee Onboarding). Ensure ongoing adherence through coaching and appropriate use of metrics.
GMP experience is essential though this is not a training delivery role. The key requirement is a solid understanding of learning systems preferably SAP SuccessFactors and the capability to design curricula aligned to specific roles.
Experience supporting Operations QC or Supply Chain functions in the biopharma industry would be highly advantageous.

Educational and Experience Requirements

Degree qualification (Science/Quality/Technical/HR).
Proven record of accomplishments of working in a Pharma/Biopharma company or related industry is desirable.
Proven ability around working cross functionally focusing on meeting and tracking to schedules and embracing an interdependent work culture.
Experience working in a GMP/regulated environment is desirable.
Organisation Skills Ability to manage multiple priorities and know when to escalate issues for resolution.

Other Job Requirements:

Minimum 2 years L&D experience in a manufacturing environment
Preference Lean Six Sigma
Ability to think logically and be proactive under pressure.
Ability to work as part of a team and on own initiative in a constructive manner.
Flexible and self-motivated.
Strong in analysing data building metrics and using visualisation tools.
Working knowledge and application of Instructional Design Adult Learning Principles and Evaluation Methodologies.

Required Skills:

Minimum 2 years L&D experience in a manufacturing environment Preference Lean Six Sigma Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner.

Required Education:

Minimum 2 years L&D experience in a manufacturing environmentPreference Lean Six SigmaAbility to think logically and be proactive under to work as part of a team and on own initiative in a constructive manner.

About PSC Biotech Who are wePSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutio...