GxP Compliance Consultant

Company Description

SeerPharma's mission is to advance Quality and Good Manufacturing Practice (GMP) Best-Practices to Pharmaceutical and Medical Device companies in the Asia-Pacific region. We achieve this by offering training, consulting, software, and contract employment services addressing the Quality and GMP compliance issues companies face. SeerPharma has assisted firms involved with and/or conducting step(s) of manufacturing pharmaceuticals and medical devices for over 35 years. We have an outstanding history 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 vast cross-section of the major international standards, including PIC/S, FDA, EU, WHO, ISO and ICH.

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 your knowledge, due to the variety of work that we do.

A full-time position has arisen for a self-motivated GxP Compliance Consultant to join the SeerPharma GxP Compliance team. This role is pivotal as SeerPharma has secured several major projects and has a pipeline of ongoing work in the Pharmaceutical (API and Finished Products), Medical Device, Life Science and Veterinary product industries.

The successful candidate will have a strong knowledge of Quality and Compliance with respect to GMP as applied within Australia and internationally. This will ideally include experiences as diverse as QMS/PQS design and implementation, cleaning validation, equipment qualification, internal and supplier qualification audits, quality mentoring, and demonstrate a willingness and initiative to share knowledge with our current team of experts. An understanding of GCP, GLP, G(QC)LP and GWP would be an advantage.

The role will report to the GxP Compliance Manager, and be primarily located in Sydney, Melbourne or Brisbane with flexibility for some remote work.

 Key Responsibilities:

• Plan, author and execute (where needed) Qualification and Validation documents – VMP, URS, DQ, IQ, OQ, PQ, PV and summary reports.
• Provide subject matter expertise in equipment cleaning validation, test method validation and process validation, including sterilisation
• Review and assess client’s GxP documentation for compliance with GxP
• Author GxP compliance documentation – SOPs, WIs, policies, reports, quality records, SMF and templates
• Perform internal and supplier qualification audits and gap assessments focusing on efficient report preparation
• Support regulatory site inspection readiness programs
• Provide training online and in-person
• Provide technical advice for clients such as approach and rationale for qualification/validation activities

Key Personal Attributes:

• Pragmatic and technical-based approach
• Excellent technical writing skills
• Highly proficient in Microsoft 365 (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 to multi-task and adjust to a change in priorities
• Ability to work within a team, as well as independently
• Excellent time management skills
• Excellent communication skills
• Willing to travel and work on sites within Australia and internationally

Requirements:

• Science or equivalent Tertiary Qualification
• 10+ years of relevant experience working in or with therapeutic goods manufacture (or be able to demonstrate an equivalent depth of experience)
• Proven track record in GxP Quality and Compliance within the pharmaceutical, life science, veterinary or medical device industry
• Strong understanding of therapeutic goods regulated environment including PIC/S requirements for quality, compliance, auditing, qualification and validation