Computer Systems Validation Specialist

2 weeks ago

Melbourne, Australia Bell People Consultants Full time

Global Pharmaceutical Organisation
- Long Term Contract Validation Opportunity
- Melbourne Based Location

**About 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 Specialist** for major project validation work.

**About the Opportunity**

**Key duties include the following**:

- Define validation strategies for CSV systems, maintain & support IT Quality related process & IT document management systems.
- Execute CSV deliverables, write and review CSL documentation (IQ, OQ & PQ) plans, reports, specifications & other documentation.
- Plan & coordinate all computer systems validation activities including the drafting & review of all key validation documentation.
- 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 CSV regulations & SDLC guidelines for life sciences & best practices.**:

- **Experience with Automation & MES Project highly desirable.**:

- Strong technical & analytical skills with the ability to manage complexities.
- Understanding of industry standards & computerise systems to 21 CFR Part 11, Part 820, Annex 11, GAMP5.
- Strong project management skills.

**Culture & Benefits**
This is a challenging & excellent opportunity for a talented individual with sound computer systems validation (CSV) experience to join a large global pharmaceutical organisation to further develop their skills & experience within the CSV area.

**This is a long term contract position with high possibility of an extension.**

**How to Apply**

For a confidential discussion on this opportunity, please call Sue Campbell on 0417 994 917 or Malavika Menon on 0420 665 171

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