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.

Detailed Job Description

Responsible for Vendor Qualification, Notifications assessment and Handling of materials complaint which will cover RM/PM vendors, distributors, third party, CMO and service providers.

To adhere with the cGMP & GDP principles and to maintain them in an effective manner.

Key Responsibilities & Key Result Areas

Act as point of contact for vendor notifications for quality related issues and changes.
Performs qualification/ requalification of vendors and distributors; in addition to material complaints handling and close out with vendor.
Provide leadership and strategic direction for the QA sub-function while ensuring proper partnership and communication with vendors and internal partners
Manage vendor’s compliance to establish quality standards and any applicable testing, including federal, state, and industry safety and regulatory requirements; interpret inspection and test results, identify need for corrective actions, and manage vendor follow up.
Create and manage vendor scorecard program to document and measure vendor performance against established metrics.
Identify training needs and organize training interventions to meet quality standards.
Performs evaluation, assessment and qualification for service providers.
Review, evaluate and approve all the documents received from the vendor
Include the vendor in the approved vendor list, maintain, and update the list.
Ensure timely receipt of responses from all applicable vendors and CMOs.
Performs investigations and raise change controls pertaining to the Raw Material/API/ Vendors.
Update the ongoing Vendor related updates in the Quality Council.
Responsible for eQMS (Change Control, CAPA, Deviation investigation) related to Vendor Management (External Quality).
Responsible for any vendor Notification follow up.
Responsible for Vendor Management (External Quality) KPI for the Quality Council.
To Perform any other work assigned by External Quality Senior Manager / QA Compliance Head.
Ensure compliance with current Good Manufacturing Practices, Good Documentation Practices, applicable ISO standards and other areas of mandatory regulatory oversight.
Assist with corporate and/or third-party audit and inspection readiness program.
Maintain proper system related KPIs’ and trending in a way that allow continuous improvement culture.
Keeps up to date with all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.), in compliance with regulations.
Ensure compliance with current GXP guidelines

Core Competency

Solid Technical knowledge with strong implantation skill, people management skill

High on communication and collaboration, having an ability to manage multiple stakeholders at a time
In terms of competency, you are highly result oriented with strong sense of accountability & ownership.
In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping
Methodical and diligent with outstanding planning abilities an analytical mind able to "see" the complexities of procedures and regulations. Excellent communication skills
Business acumen partnered with a dedication to legality.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Good command in English (Communicating, writing and speaking)
KPI management, proven experience in conducting Risk Assessments.
Problem Solving and high agility on taking right scientific decisions

Qualifications

Education: 4 years Bachelor degree or master's degree in pharmacy/chemistry / chemical engineering is mandatory.
MBA or MS in Quality Management a plus
Experience of minimum 7-10 years in pharmaceutical industry in Quality Management systems is mandatory
Proven understanding and experience in sterile, non-sterile operations & change control system management
Excellent knowledge of reporting procedures and record keeping.
Prior experience in handling similar roles will ensure better fitment

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

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