An L&D Compliance Specialist is required for a biopharmaceutical company in West Cork. The incumbent will work with the L&D and MPS team within Strategy & Enabling Programs department to maintain all aspects of compliance within the team. They will be the Permanent Audit Readiness representative for the team.
- They will coach the team on compliance red flags and work closely with QA.
- They will also partner with different departments to drive the development of personnel through training and development programs, courses and other learning methodologies.
- The leadership style will be one of collaboration, coaching.
- This will require a substantial amount of his/her time within the various areas, engaging and communicating with all team members and proactively working with the leadership of those departments to drive training and development for team members.
- This individual will work with business areas to implement and ensure adherence to the site’s learning processes/system and will work with their peers to continuously improve the learning processes through to foster a continuous learning environment.
- Interprets internal and external regulatory and compliance developments and communicates action to Department and site as appropriate.
- Ensure that departmental procedures are aligned with corporate standards and policies.
- This scope will cover EHS, GMP and Quality management System (QMS) standards.
- Enables Permanent Inspection Readiness and cGMP Compliance as it relates to Training/Learning & Development for the Site.
- Through collaborative and open team members in the compliance requirements.
- Assist them in formulating corrective plans where required and putting a process in place confirming that actions are addressed.
- Be responsible for GMP Tier process.
- Own QN,CAPA processes using effective Root Cause Analysis (RCA) methodologies.
- Establishes relationships with site cross functional areas (IPT, Support Functions, GSFs and CoEs) to understand the business objectives and collaboratively defines learning and develop strategies that enable run the business activities as well as future growth.
- Conducts learning needs assessments and/or job analyses with client to identify relevant learning plans and solutions.
- With the business areas, implements learning and development plans inclusive of job and functional skills.
- Monitors progress with appropriate documentation and metrics and defines opportunities for continuous improvement.
- Qualifies and coaches’ trainers and classroom facilitators within client group to ensure optimal delivery of training programs.
- Ensures implementation of global, site and local area training programs, as needed.
- Delivers assigned routine training as required.
- Works collaboratively within the Learning organization to implement, maintain and continuously improve site learning processes utilizing our company Production System (MPS) and innovative technologies (i.e. Job Skills Qualification, SOP Process, Annual GMP, Safety Programs and New Employee Onboarding).
- Support any Environmental, Health and Safety (EHS) or Quality Compliance regulatory audits as required.
- Collaborate with Global Learning and Development, Learning Support
- Services and other manufacturing sites to implement best practices.
Qualifications & Experience:
- Bachelor’s Degree or equivalent (Science/Engineering).
- At least 3 to 5 years’ experience in the Pharmaceutical industry in a GMP compliance role.
- Strong knowledge of the Learning & Development processes.
- Strong business knowledge.
- Demonstrated coaching/facilitation skills.
- Experience using a Learning Management System (LMS).
- Working knowledge and application of Learning Principles and Evaluation Methodologies.
- Strong knowledge of documentation and change control processes.
- Experience in dealing with internal and external compliance audits.
- Desirable: Six Sigma Yellow/Green Belt.
- Desirable: L&D Experience.
To apply for this job email your details to firstname.lastname@example.org.