Qualified Person at Johnson & Johnson Innovative Medicine

Job Description:

Latest job information from Johnson & Johnson Innovative Medicine for the position of Qualified Person. If the Qualified Person vacancy in Munster matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Johnson & Johnson Innovative Medicine for the position of Qualified Person below matches your qualifications.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at

Job FunctionQuality

Job Sub FunctionQuality Assurance

Job CategoryProfessional

All Job Posting Locations:Little Island, Cork, Ireland

Job DescriptionPOSITION SUMMARY: This position is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice.

General Scope Of Responsibilities

• Responsible for certifying DSP batches prior to release to filling site
• Ensures that product manufacturing, testing and release comply with applicable regulatory requirements and specifications prior to product release
• Maintains oversight of Quality issues and change controls, ensuring that any issues that have a regulatory impact are notified to health authorities and mitigated as required
• Attends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
• Maintains knowledge and understanding of quality oversight for services and operations which are outsourced to CMOs / contract test labs
• Maintains Qualified Person (QP) knowledge and experience up-to-date. If a new product type is introduced the QP must ensure that they have gained the relevant knowledge and experience necessary to complete QP duties.
• Maintains oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as required.
• Supports QA colleagues with product quality / license impact assessment for Quality Issues.
• Review and approval of Quality documentation associated with product manufacture.

Key Competencies Required

• Excellent interpersonal skills
• Management skills: Problem solving; statistical thinking; design of experiments
• Keeps up-to-date with the regulatory, technical developments in the industry that will affect products on-site
• Excellent attention to detail
• Maintains focus on patients and customers at all times
• Maintains the highest standards of ethical behavior

Qualifications And Experience (essential)

• Have fulfilled the educational requirements as outlined in Article 49 of Directive 2001/83/EC with at least 2 years Qualified Person experience within regulated biologics / pharmaceutical industry
• Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.

Required SkillsPreferred Skills:Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

Job Info:

• Company: Johnson & Johnson Innovative Medicine
• Position: Qualified Person
• Work Location: Munster
• Country: IE

How to Submit an Application:

After reading and understanding the criteria and minimum qualification requirements explained in the job information Qualified Person at the office Munster above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.