Job Responsibilities:1. Perform analysis procedures mainly bioburden testing, spectrophotometric testing and mechanical studies using UTM machines2. Ensure product stability studies are completed satisfactorily and supported by correct product sample analysis3. Also, whenever required provide support to Marketing by educating customer4. Establish a tracking mechanism for customer & field complaints and suggest corrective actionsProfile:1. You have experience of around 3 or more years in pharmaceutical industry2. Educational Qualification - M.Sc./M.Pharm degree with strong interest in quality control3. You work accurately, technically minded and able to work independently after training in the matter entrusted to you. Experience in a formulations/ API industry is an asset

Background Industry: Medical Devices (EU Class 2b or higher) manufacturing company with turnover higher than 300 CrRequired Skills:Experience in QA management across multiple projects involving the implementation of the Company's QA processes and strategies. The projects include IPQA, QMS, validation and Compliance related assignmentsEnsure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for EU MDR, PMDA, SFDA, TGA and KFDA requirementsExcellent knowledge of QA processes including of risk management, clinical data management and electronic data management systems. Ability to handle adverse events and rectify non conformities reported in inspections

1. Implement and maintain the quality system on the lines of ISO 13485 and GMP2. Responsible for control of all levels of documents & their history in accordance with EU MDR3. Coach and Guide the team to support company goals by :Identifying factors that are critical to qualityImproving capabilities & increasing stability of process control measuresParticipate in the new product registration/ life-cycle management discussions to provide inputs on the procedure for analysis, mainly validations

Responsibilities:Plan and manage development of high-quality regulatory documents including CTA, & Post Market Surveillance (PMS) reports and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirementsEnsure all filings (including DMFs) are maintained as per the regulatory requirements and consistent with the product development and life cycleParticipation in regulatory meetings with Health AuthoritiesRecommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.Knowledge:Working knowledge of 510(k), MDR 2017/745 and working knowledge of 21 CFR 820 -Quality System.

Role & responsibilities Customer Support: 1. Answer customer inquiries via phone, email, chat, or in person. 2. Provide product/service information to customers. 3. Assist customers in troubleshooting issues.Issue Resolution: 1. Handle complaints and provide appropriate solutions within a set time frame. 2. Escalate complex issues to higher management if required.Order Processing & Follow-ups: 1. Process orders, applications, refunds, or requests as needed. 2. Follow up with customers to ensure their concerns are addressed.Documentation & Reporting: 1. Maintain accurate records of customer interactions. 2. Prepare reports on recurring issues and customer feedback.Key Skills Required:Excellent communication (verbal & written)Problem-solving and conflict resolution skillsPatience and empathyGood listening skillsAbility to multitask and work under pressureBasic computer proficiency (MS Office, etc.)Eligibility Criteria:Education: Any Graduate.Experience: 0-3 years in customer service or related roles.Language: Proficiency in English & local language is a plus.Park & Benefits:Salary: Rs.15,000/- to Rs.20,000/- per month, depending on experience and company.Company provides transportation facility from Vadodara to Plant.