Job Description

Company : Our client MNC dealing in Pharmaceutical Products / Consumable / Medical Device. Position : Quality Assurance Specialist Job Location : Thaltej (Ahmedabad) Job Summary Facilitate and support the implementation of quality management system and compliance with global procedures. Overall compliance for prequalification of product following defined procedures. Support to assigned business segment as QA responsible person and shall act independently where quality driven task and decision making involved. Shall support the quality function with technical skills on risk assessment, root cause analysis and implementation CAPA. Shall investigate thoroughly any new business case that requires review of compliance as per recognized guidelines and implementation of it. Support corporate QA/RA in defining, revising, and implementing QMS and Standard Operating Procedures. Shall Handle customer claims and communication with customer in close co-ordination with corporate QA including performing thorough assessment for claim investigation and CAPA. Shall work closely with manufacturer on technical development, complaints, follow up, performance monitoring and shall support manufacturer establishing effective control on all the products supplied. Active participation in developing and following up prequalification of manufacturer. Co-ordinating for third party services, inspection agencies and facilitate implementation of services from third part service provider. Assist in implementing various projects where quality function is involved and required. Review of product assessment of product executed in ERP and share point. Review and monitoring of performance of supplier from prequalification perspective. Participate in product and plant audit as support to auditors. Training of colleagues for the function of quality assurance and quality control. Required Skills/Abilities B.Pharm / M.Pharm with 5-7 years hands on experience from QA function of manufacturers of Pharmaceutical or a Procurement agency including prequalification experience based on WHO cGMP guidelines. Updated on WHO technical report series, EU GMP, MDR and ICH guidelines and able to explain and justify audit findings in a simple understandable manner. Understands and be oriented towards the ERP /SharePoint system as a tool and use it efficiently within own area of work. Active and proactive in everyday issues as a solution-oriented provider. Should be a team player and a team builder to ensure an efficient process and communication respecting core values. Should understand the role of QA/QC in the Order Life Cycle Well structured, detail oriented, strong coordinator with decision-making capabilities. Contact Person Rina Arun [HIDDEN TEXT] +91 9904322770

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