4 - 8 years
4 - 6 Lacs
Posted:3 months ago|
Platform:
Work from Office
Full Time
Role & responsibilities Managing the Quality and Information Security Management System and ensuring GMP compliance is incorporated. Agreeing standards and establishing clearly defined quality methods for staff to apply. Liaising with clients auditors and ensuring the execution of corrective action and compliance with clients specifications. Identifying relevant quality and GMP related training needs and delivering training. Guiding the relevant stakeholders on quality and regulatory requirements on innovation projects. Function as an internal auditor for QMS, ISMS, and BCP as required. Managing and developing the Document management system. Ensuring the CAPA system is managed with the objective of continuous improvement. Ensuring compliance with appropriate standards and regulation. Ensuring external audits for critical suppliers are attended to or led by a member of the quality department. Drive on-time closure of all observations, opportunities for improvement and NC’s (if any). Complying with SOPs (Standard Operating Procedures) and Work Instructions as detailed on Training Records and Training Matrixes. Effectively interact with the company departments to ensure the delivery of the product to specification and promote the improvement of the QMS. Updating of Quality Records, as detailed in the appropriate SOPs. Comply with Perigord centralised Global Quality and Information Security Management System. Provide daily / weekly update over email and review calls to the Quality Manager and Global Head of Quality Preferred candidate profile Bachelor’s degree qualification in a life science, technical or engineering discipline. 4+ years of relevant Quality Assurance or relevant experience in Life science and or Software services company Demonstrate excellent communication skills (oral as well as written) Ability to work with minimum supervision. Ability to work within a challenging environment with tight delivery timelines. Additional Desired Preferences: Knowledge of Computer System Development Life Cycle Good technical understanding of IT infrastructure Experience dealing with regulatory agencies and global audit teams.
Perigord Life Science Solutions
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