QM Supplier Quality Operations Expert

3 weeks ago

Chennai, India Pharmathen Full time

Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.

Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.

Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a QM Supplier Quality Operations Expert for the Corporate Quality Management team at India.

As a QM Supplier Quality Operations Expert, the ideal candidate will be responsible for ensuring compliance with GMP requirements and ISO standards.

More particularly:

Requirements

What you will do:

Ensure the compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and cGMPs Participate in the company’s Supplier evaluation program. Contribute to selection, evaluation qualification and periodic performance evaluation of suppliers Participate to new product launches to ensure existing suppliers or new suppliers are suitable for the required quality standards Coordinate the evaluation of Materials equivalence with the registered files Handling, monitoring, notification request of supplier’s complaints Organize, participate in Supplier audits and assess the on-site and paper based audits to the suppliers conducted by third party auditors required in order to comply with Authorities requirements for dossier submissions Participate and compile relevant risk assessment reports for the evaluation of the changes relevant to the raw materials received, in order to assist in the decision of the action plan required to implement, the relevant changes within Pharmathen’s BU sites Support the Suppliers Notifications process Participate in the main department’s processes including “Change Control”, “Corrective Preventive Actions”, “Risk Management”, “Deviation Investigation Reports” Be responsible for development and review of departmental SOPs, TDRs, protocols and any other relevant controlled quality documents related to the assigned duties Actively participate in Customers’ Audits and Competent Authorities’ Inspection Initiate and maintain the Supplier Quality Technical Agreements

The ideal candidate should have:

BSc / MSc in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or other relevant sector At least 6 years of experience in Quality Management / Assurance - experience within the pharmaceutical industry will be considered an asset

Job-Specific Skills:

Excellent communication in English language (writing & speaking) Computer literacy Ability to prioritize tasks and meet deadlines Exceptional communication skills Strong project management skills

Benefits

What you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere Exposure to challenging business issues and practices Great opportunity to leverage and develop your business knowledge and skills

J

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