Job Summary:
This role will provide support to the YBB global laboratory team and stability team in the update of documentation in line with ChP 2025 requirements. This role will also support the laboratory projects team as required with the stability program by performing tasks such as subsampling and labelling of samples for stability setdown, sending of samples to offsite stability storage, receipt of samples from offsite storage, sending of samples for AQL testing and filing of documentation in relation to stability storage.
Essential Duties and Responsibilities:
- Liase with Project leads/ Lab mgt on documentation update requirements
- Perform documentation updates as required including but not limited to updates to SOIs, GTMS, ATT and protocols
- Coordinate the review and approval of documentation through the documentation control system
- Perform stability related administration duties as required, for example labeling of bags, shipping of samples and creation of sample submissions
- Maintenance and filing of stability related documentation
- Support continuous improvement activities (Lean, 6s)
- Maintain cGMP, GLP, GDP and ISO compliance
- Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all local site Environmental, Health and Safety regulations.
- Compliance to all local site company policies, procedures and corporate policies.
- Other duties as required to support the laboratory projects team and stability program
Basic Qualifications:
- Cert or Dip in a Science discipline an advantage but not required
Preferred Knowledge, Skills and Abilities:
- Experience in a cGMP facility or Laboratory environment an advantage.
- Experience with Microsoft Word and Excel
- Good verbal and written communication skills
- Excellent organizational skills
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.