1.0 JOB TITLE : Associated Junior Executive – QA & QC
2.0 REPORTS TO : Associate Manager – QA & QC
3.0 DOWNLINE REPORTING : None.
4.0 JOB RESPONSIBILITIES :
4.1 Ensure Safe and Health environment in Work place.
4.2 Preparation of IQA schedule, follow-up on execution of IQA, compilation of audit finding & report preparation, follow-up for closing the AARs.
4.3 Assist the Management Representative in conducting the MRM and collecting the relevant information required for the meeting. Follow-up with the responsible persons to execute the decisions / actions taken in the MRM.
4.4 Ensure and update the procedures as per the new / Regulatory requirements.
4.5 Ensure Control of Documentation and their Distribution.
4.6 Ensure that Suretex Quality Management System is in line with all the standards applicable to us. Maintain the quality system in such a way that external audits like USFDA, BSI, SABS Product permit audits, inspection by the authorities of Drugs Control Department of Karnataka, etc., are faced successfully in any point of time.
4.7 Co-ordination with External auditing agencies / Certification Bodies for conducting the Audit and follow-ups.
4.8 Communicate with responsible persons of the Notified Bodies (like USFDA, BSI, Drugs Control Department of Karnataka and others) and up-date the necessary information required for the business. Co-ordinate with Quality Management team and regulatory in-charges of various regions, to adhere to the regulatory requirements of each region covered.
4.9 Monitor the manufacturing process, in case of changes that occurred due to Validations, process developments, design changes or new product development, assess the need for new approval and inform the assessment to Manager / Sr. Manager – QA.
4.10 Handling of Change Controls and Concession Notes.
4.11 Prepare required documentations for 510 (k) submission to USFDA through Regulatory Affairs Team.
4.12 Discuss with Global Regulatory Team or Marketing Team for new product registration.
4.13 Co-ordinate with the liaising person for the submission of application regarding the renewal of license, brand registration, free sale certificates and others if any with the local FDA
4.14 Review the DHR of the goods being released and ensure that the process was done in accordance with the specifications and procedures. Analyze the defects observed in the pre-dispatch test and report the findings to respective department and Sr. Manager – QA for further action.
4.15 To compile and prepare the certificate of analysis for all batches on completion of final release testing. Authorize for Final release / dispatch after completion of certificate of analysis.
4.16 Co-ordinate with external sampling / testing agencies for organizing inspection and forward samples as per requirements. Follow-up for the results.
4.17 Compare the results of external lab and in-house results. Participating in inter-lab trials and summarizing the findings.
4.18 Register and investigate all the complaints / feedback received from the customer, analyze the DHR and report the findings with correction / Corrective actions. Respond to the complainant on time.
4.19 Follow-up for the effective implementation of all Corrective actions taken from complaints, non-conforming products, IQA’s process non-conformances etc., and reporting to MR.
4.20 Ensure and target to achieve Quality KPIs.
4.21 Follow-up with the respective personnel for the initiation of material review board, change request, CAPA and document the same.
4.22 Involve and co-operate in the implementation of best practices initiatives.
4.23 Focus on Company vision & shares its values. Exhibit commitment to business ethics & demonstrate high level of personal integrity.
4.24 Should be aware of the EHS Policies & Procedures. Ensure no injuries at workplace. Reporting of EHS activities / concerns / incidents / near miss / accidents.
4.25 To Follow Safety, Health and Environmental procedures such as safe work practice, IS0 14001 activities, maintaining safety calendar and 5S activities on a monthly basis and to conform with the regulatory requirements, wherever relevant to the site.
4.26 This job description is subject to change by the Management to suit changing requirements from time to time.
4.27 In the absence of Sr. Manager – QA, take the responsibilities of his / her Job as described.
4.28. Ability to achieve respective QA & QC KPIs as per the targets.
4.29. Aware Quality standard requirements such as ISO 9001, ISO 13485, ISO 14001, QSR Part 820 and other applicable regulations.