AddressAbout the company
Our client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and global market. As a highly regarded & well-known organisation they are known for their operational excellence, passion for innovation and are a global leader in the healthcare industry.
Due to new project requirements, an opportunity has arisen for a talented & experienced Computer Systems Validation (CSV) Specialist to review & address audit findings related to data integrity, cGxP & ALCOA Principles.
About the Opportunity
This is a Challenging & Excellent Opportunity for a talented individual with sound Computer Systems Validation (CSV) experience with cGxP & ALCOA principles to join a large global pharmaceutical organisation to address audit findings & data integrity.
Additional informationOur client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and global market. As a highly regarded & well-known organisation they are known for their operational excellence, passion for innovation and are a global leader in the healthcare industry.
Due to new project requirements, an opportunity has arisen for a talented & experienced Computer Systems Validation (CSV) Specialist to review & address audit findings related to data integrity, cGxP & ALCOA Principles.
About the Opportunity
Key duties include the following:
- Review & address audit findings related to data integrity, cGxP & ALCOA Principles.
- Independently access audit findings against legacy systems in relation to MOD 300 and PCS7 Systems.
- Write & review CSL documentation (IQ, OQ & PQ) plans, reports, specifications & other documentation.
- Liaise with Subject Matter Experts (SME's) on CSL tasks & findings.
- Coordinate all validation documentation ensuring all documents are written to global standards.
- Effectively liaise with all stakeholders and Subject Matter Experts.
- Tertiary Qualifications in IT Computer Systems or similar.
- Minimum 5 years experience in CSV methodologies within the pharmaceutical industry.
- Demonstrated knowledge & experieince in GxP, AlCOA Principles.
- Sound technical & analytical skills with the ability to manage complexities.
- Understanding of industry standards & Computerised systems to 21 CFR Part 11, Part 820, Annex 11, GAMP5.
This is a Challenging & Excellent Opportunity for a talented individual with sound Computer Systems Validation (CSV) experience with cGxP & ALCOA principles to join a large global pharmaceutical organisation to address audit findings & data integrity.
This is a Contract Position requiring Immediate Start.
How to Apply
For a confidential discussion on this opportunity, please call Sue Campbell on 0417 994 ***.
To apply for this role, please click the LINK below & send your CV in MS Word.
NB - Only shortlisted candidates will be contacted.
- Global Pharmaceutical Manufacturing Organisation
- Contract Opportunity - Start ASAP
- Melbourne Based Location
