The GMP Quality Support role is a new and exciting role within Bidvest Noonan. The successful candidate will be responsible for providing essential quality support to GMP processes, working closely with various clients to ensure the best standard of GMP service delivery and to optimise workflows and processes to ensure that we are always industry leaders. This role with report directly to the GMP SME/Microbiologist.
Daily tasks will vary from providing procedural input, supporting operatives and clients across various locations, facilitating process optimisation, performing GMP investigations and reviews, writing reports, providing relevant trainings and promoting an environment where compliance is key. This role is hands on, will require travel and flexibility and a responsible person who takes pride in their work.
Key Responsibilities Include:
- Ensures compliance with cGMP’s, Environmental, Health & Safety regulations.
- Executes all Quality Control activities to ensure timely & compliant delivery of services
- Researches and assists with implementation of regulatory guidelines across different contracts
- Prepares and executes method development, validation plans, quality assurance policies and procedures for the business and clients as required
- Researches and evaluates the facts surrounding process deviations and defects by conducting audits
- Documents quality assurance activities and creating audit reports.
- Identifies and resolves workflow and compliance issues
- Liaise with other groups and individuals to ensure planning of tasks is effective
- A keen eye to identify new industry patterns and provide analysis on process adherence and risk involved in the processes
- Develops and provides insight into standard operating procedures
- Supports approved projects and continuous improvement initiatives that are in alignment with business and site strategies.
- Succinctly communicates trends and actionable solutions to leadership and operational stakeholders.
- Good process acumen to develop strategic policies to ensure to invent and simplify the process further.
- Produces reports on defect trends and root causes, perform data-mining and analysis to support programs as well as identify new metrics and opportunities for quality improvements.
- Take proactive ownership when identifying process gaps/ defects – if the process is owned by another department take the lead in identifying, communicating and helping the owning team to resolve the gap/issue.
- Creating new training materials and operating manuals
- Be an advocate for continuous improvement
- Promotes the maintenance of a safe, accident free and healthy work environment.
- Performs related duties as assigned
Experience and Educational Requirements:
- A science qualification in an engineering or science-based discipline or equivalent
0 to 3 years’ experience in the biotechnology and/or pharmaceutical industry or equivalent
- Certificate in quality assurance is a plus
- Previous experience in quality assurance or a similar field
- Working knowledge of tools, methods, and concepts of quality assurance
- Solid knowledge of relevant regulatory standards
- Good communication skills, both verbal and written in English
- Excellent data collection and analysis skills
- Strong attention to detail
- Ability to think logically and be proactive under pressure
- Flexible and self-motivated
- Manual handling and safe pass a plus
Please note that a valid Class B driver’s license and legal right to work in Ireland are mandatory requirements for this position.
This position is not a shift position, with roughly 39 working hours spread between Monday and Friday weekly. An initial 6-month probation period will apply after with the position may become permanent.
Please review our Privacy Notice – Bidvest Noonan for details on the personal data collected when you apply for a job with Bidvest Noonan and the purposes for which this personal data is collected. We will not retain any CV’s or job applications for longer than necessary to evaluate and process your application.
To apply for this job email your details to Tessa.Rossi@bidvestnoonan.com.