Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

The focus for the Quality Specialist is to act and perform QA and PV activities in compliance with Good Distribution Practices Principles and Good pharmacovigilance Practices for medicinal products. Also responsible for the regulatory submission, approval and registration and Life Cycle Management, other statutory licenses related to medicinal products, medical devices and In Vitro Diagnostic products.

The countries under the scope of this Quality Specialist are India, Sri Lanka and Bangladesh.

What your main responsibilities will be

You will have the opportunity to:

• Implement and/or maintain a quality system and requisite certification as per Local regulation and Grifols Requirement.

• Comply, track and Maintain the Local Quality Assurance Plan based on Corporate Quality Plan.

• Manage QA operations for Grifols India ensuring all Quality Procedures are prepared, reviewed, implemented and complied harmonizing Grifols Corporate Quality requirement and ensuring local statutory requirements.

• Perform Customer Qualification and renewal via Physical and Remote Audit.

• Prepare and Participate in Corporate and Internal Audit. Perform Internal Audit as and when required in Grifols India.

• Mange 3PL Quality Operation including repackaging operations. Monthly Visit to 3PL, Engage 3PL Quality team as per the Plan and schedule.

• To assure distribution activities to be in compliance with Good Distribution Practices of medicinal products.

• Learn and execute operation via QMS tools and software like SAP, Documentum, LSQM, COSMOS etc.

• Perform QA Training of Grifols Employees and Contractual Partner.

• Act as Local Quality Contact Persons (Alternative contact/ TD Designee).

• Cross-function coordination and collaboration with Global, Regional and Local Departments – Regulatory Affairs, SCM, Marketing, Medical Affairs, Manufacturing and external customers (Consultant etc.) for seamless organizational operations.

• Local Back-up contact for pharmacovigilance (Alternative contact) and reactovigilance.

• Compile to local PV SOP and Local Regulation and ensure safety report collection, timely submission to Global PV team and obtain CIOMS to comply reporting to HA.

• Perform Risk Assessment, Business Continuity Plan (BCP) of Technical Area and Mock Recall.

• Track and update local PV regulation & Global PV and shall update local SOP as and when required.

• Manage procurement and submission of aggregated safety information.

• Support Regulatory and Tender business requirement and Manage the interaction and follow-up with National Health Authorities.

Who you are

The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• You are a graduate in Pharmacy or Biotech or Biology or other relevant streams.

• You have at least 3 years of experience in a similar position taking care of Quality and Regulatory affairs matters in the country. Experience in the implementation of a Quality System based on ISO 9001 is preferred

• You have a good understanding of procedures within a multinational company.

• You are an effective communicator, oriented to results, multitasking and rigorous.

• You have availability to travel.

What we offer

This is a a brilliant opportunity for someone with the right talents.

Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.

We look forward to receiving your application.

Grifols is an equal opportunity employer.

• You have availability to travel.

• Benefits package.

• Contract of Employment: Permanent position.

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Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Req ID: 524202

Type: Regular Full-Time

Job Category: Quality