Quality Systems Specialist

2 days ago

Wellington, Wellington, New Zealand Merck Gruppe - Msd Sharp & Dohme Full time

Job Description
Quality Systems Specialist Looking for a different challenge as a Quality Systems Specialist whereby you can still utilise your skills?Permanent Full-time position with competitive remuneration and benefitsWork with a dedicated and welcoming teamUpskill and growth in an area you are passionate about, whilst being fully supported and encouraged.Join a Trusted Global Leading Animal Health organisationThe primary responsibility of the Quality Systems Specialist is to support continuous improvement of our quality systems related to manufacture and supply safe biological products.
This will leverage Quality and Compliance Excellence principles in relation to system and sub-system ownership and inspection readiness.
What You Will Do Responsibilities include, however not limited to: Quality - Compliance Maintain and monitor Quality Systems and programs related to compliance and product safety to ensure compliance with regulatory and AHQM requirements such as personnel training, seed management, stability, equipment requalification, Qualifications and Validations, compliance of inwards goods release, AHQM compliance and document reviews.Ensure Compliance to Company and regulatory requirements.Develop and maintain stability, seed and sample retention programs, real-time trend analysis in line with regulatory requirements and AHQM requirements.Perform quality review and administration of new and updated controlled documents for GMP and regulatory compliance.Auditing May audit and evaluate current policies, procedures, and documentation for compliance with government laws and regulations.Participate in auditing of company GXP related systems and processes.Perform internal and supplier audits and generate formal reports as required.Communication Provide information to requests with the assurance that the data is valid and accurate.Provide support to the business as a whole where requested.Work as a facilitator, coordinate activities to enhance the performance of the group or project.Quality Management Sub-System Owner Be responsible for the ownership of the AHQM Sub-Chapters as nominated and agreed by the Site Quality Head (e.g.
Complaints, Personnel, Training, Seeds Management, Stability etc.
)
Pharmacovigilance (PV) Responsibilities Completing training in assigned area/tasks.Follow global and local procedures to ensure that you are familiar with the required reporting processes and timelines for Adverse Events and Product Quality complaints.Lead customer complaints investigations as requested.What You Must Have Education Bachelor's degree or higher in science-based discipline (such as chemistry, microbiology).
Experience Understanding and knowledge of Quality Assurance (QA) systems, Good Laboratory Practice (GLP), Quality Control and Good Manufacturing Practice (GMP) Requirements.Previous technical experience in reviewing method validation/verification, validation/qualification, and stability reports.Minimum of 5 years experience in a Quality Assurance/Control in a technical capacity in a GMP/GLP environment.Previous auditing experience essential.Attention to detail when reviewing technical and other documentation for accuracy and completeness.Excellent written and verbal communication skills and the ability to positively influence others.Computer skills: High level of proficiency - Excel, Word, Access, Outlook, SAP.What you can expect Work autonomously whilst being supported, encouraged, and being part of a trusted, leading Global Animal Health organisation.Exposure to upskill and develop in your role.Joining a collaborative team of like-minded individuals.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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