Title: Specialist - QA Vendor Management
At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
Job Summary/Main Purpose:
To adhere with the cGMP principles and to maintain them in an effective manner. Responsible for Quality Assurance functions of Vendor Management.
Key Responsibilities & Key Result Areas
- Act as second line and program co-owner for new vendors’ introduction, qualification, and assessment.
- Act as point of contact for vendors’ notifications for quality related issues and changes.
- Oversee the quality oversight program for vendors; in addition to material complaints handling and its close out with vendor.
- Act as the site point of contact for service providers’ evaluation, assessment, and qualification.
- Ensure that new product launches and new vendors-related changes are deployed correctly and in compliance with regulatory expectation.
- Ensure timely manners reporting of potential violation or non-compliance issues to the reporting manager.
- Investigate material complaints related to raw and packaging materials
- Evaluate corrective and preventive action (CAPA) responses to the assessment findings for adequacy, including root cause and timeliness.
- Ensure timely receipt of responses from all applicable vendors. Review Approve and Maintain responses.
- Issue and Review contractual agreements (e.g. Quality Assurance Agreements) for vendors, third parties, service providers and CMOs
- Review and approve batch record documents, investigations and change controls for CMOs.
- Service providers qualification management.
- Maintain proper system related KPIs’ and trending in a way that allow continuous improvement culture.
- Handling of deviations and investigations.
Core Competency
- In-depth knowledge of the industry’s standards and regulations guidelines.
- Excellent knowledge of reporting procedures and record keeping.
- Business acumen partnered with a dedication to legality.
- Methodical and diligent with outstanding planning abilities.
- An analytical mind, able to “see” the complexities of procedures and regulations.
- Excellent communication skills.
Qualifications:
Key Experiences / Functional Knowledge Requirements:
- Education: Bachelor’s degree in science/pharmacy / health care related.
- Experience of overall 6+ years in Quality assurance with 3-5 years in vendor management and QMS is required
- SAP basic knowledge.
- Proven experience in vendor management to resolve quality issues is an advantage.
- Good computer knowledge and knowledge of QMS systems.
- Quality and Business decision taker.
- Good knowledge and command in cGMP.
- Prior experience in handling similar roles will ensure better fitment.
- Excellent command in English (communicating, writing and speaking) Good Knowledge and command on cGMP and audit readiness.
- Effective oral & communication skills.
- Reliability, teamwork and influencing skills.
- Computer knowledge and proficient in English.
We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar