Quality Systems Specialist

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 renumeration and benefits
• Work with a dedicated and welcoming team
• Upskill and growth in an area your passionate about, whilst being fully supported and encouraged.
• Join a Trusted Global Leading Animal Health organisation

The 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 principals 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
• Performs 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, co-ordinate 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 likeminded 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Requisition ID:R332683