GxP Compliance Contractor (Singapore, Sydney, Melbourne, Brisbane)

GxPComplianceContractor

Company Description

SeerPharma'smission is to advance Quality and GMP Best-Practices to Pharmaceutical and Medical Device companies in the Asia-Pacific region. We look to achieve this by offering training, consulting, software, and contract employment services addressing the Quality and GMP compliance issues companies face. SeerPharma hasassistedfirms involved with and/or conducting step(s) of manufacturing pharmaceuticals and medical devices for over 35 years. We have an outstanding track record of successful work with a broad client base across the APAC region, and a great team of over 30 consultants and trainers assisting with a wide range ofmajor international standards, including PIC/S, FDA, EU, WHO, and ISO.

We have a friendly and inclusive culture and testimony to this is the length of time our staff stay at SeerPharma. It is also an excellent opportunity to increase the breadth and depth of yourknowledge,due to the variety of work we do.

A Contractor position has arisen for a self-motivatedGxPCompliance Contractorto join the SeerPharmaGxPComplianceteam. This role is pivotal as SeerPharma has secured several majorprojects andhas a pipeline ofongoingworkin the Pharmaceutical,Medical Deviceand Veterinary productindustries.

The successful candidate will have a strongknowledgeofQualityand Compliance activitieswithin the GMP, GCP, GLP, G(QC)LP, GDPand/orAPVMA spaceideallyincludingexperiences as diverse asQMS/PQSdesign and implementation,cleaning validation, equipmentqualification, internalandsupplier audits, quality mentoring,plus demonstrate a willingness and initiative to learn from our current team of experts.

The role willreport to theGxPCompliance Manager, andbeprimarilylocatedinSingapore, Melbourne,Sydneyor Brisbanewith flexibility for some remote work.

For more background on our GxP Consulting business, do visit:

https://www.seerpharma.com/services/gxp-consulting/gxp

Key Responsibilities:

• Plan,authorand execute(where needed)Qualificationand ValidationdocumentsVMP, VPP, URS,DQ, IQ, OQ, PQ.
• Reviewand assess client'sGxPdocumentation for compliance withGxP
• AuthorGxPcompliance documentation SOPs,WIs,policies,reports, SMFand templates
• Performinternal and supplier audits and gap assessmentsfocusing onefficient report preparation
• Support regulatory site inspection readiness programsincluding training
• Providetechnical advice for clients such as approach and rationale for qualification/validation activities

Key Personal Attributes:

• Pragmatic and technical based approach
• Excellent technical writingskills
• Highly proficient in Microsoft365 (Word, Excel, PowerPoint etc)
• You take pride in the quality of your written work
• Ability to work efficiently within a defined scope of work
• Ability tomulti-task andadjust to a change in priorities
• Ability to work within a team, as well as independently
• Excellent time management skills
• Excellent communication skills
• Open to travel and working on-site