Quality Assurance specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at Innovative Medicine is recruiting for a(n) Commercial Quality Assurance Specialist located in Hungary.

As a Quality Assurance Specialist you will:

Provide hands-on Quality Assurance (QA) support for commercial operations at the Hungary LOC. Ensure timely adequate batch release documentation maintain controlled documents support training as Subject Matter Expert (SME) and assist with QSMR and PQC processes to enable agile product supply.

The responsibilities and the impact YOU will have:

Batch release documentation

• Review and prepare batch-release related documentation in accordance with internal procedures and applicable regulatory/GDP requirements.
• Liaise with manufacturing QC supply chain and 3PL to resolve release-related queries and expedite decisions.

Training Subject Matter Expert & training support

• Serve as SME for QA-related training topics (GMP release documentation deviations complaint handling document control).
• Provide training needs identification deliver training sessions and support proficiency assessments for commercial QA activities.
• Maintain training records and supervise efficiency of training interventions.

Document control oversight

• Act as Document Controller for assigned QA documents (SOPs work instructions templates).
• Coordinate document impact assessments for changes to processes specifications or documents; identify downstream impacts.
• Ensure controlled document lifecycle: creation review approval distribution archiving and obsolescence.

QSMR support

• Support preparation and follow-up for Quality System Monitoring Reviews (QSMR) or equivalent quality management reporting (data collation trend analysis metric updates).
• Input on CAPA and continuous improvements highlighted by QSMR outputs.

Product and customer related complaints handling

• Receive triage and support investigation of PQCs (Product Quality Complaints) in line with procedures.
• Coordinate with cross-functional teams (Regulatory Medical Manufacturing QC) on complaint assessment root cause analysis and corrective/preventive actions.
• Ensure timely communication and documentation of complaint outcomes and trending.

Additional accountabilities

• Participate in change control deviations investigations and batch record reviews as required.
• Support internal and external audits/inspections by providing documentation and subject matter input.
• Drive continuous improvement initiatives to reduce quality risk and enhance documentation efficiency.

We would love to hear from YOU if you have the following essential requirements:

• Completed university education with Previous experience in Pharma Business.
• Problem solving oriented and ability to work autonomously.

• Ability to work precisely without errors of a formal and factual nature and systemically.
• Ability and willingness to work hard multitasking.
• Flexibility and willingness to learn new things.
• Communication skills.

Are you ready to make an impact

If you want to leave your personal mark and be valued for who you are Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

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