Manager QA

About Us :

Sydler Group of Companies is a leading manufacturer and exporter of excellent quality and reliable Pharmaceutical Formulations, Herbal formulations, Nutraceuticals & Dietary Supplements, and Nutritional food products, catering to discerning market needs globally. Ever since its inception in 2004, we have set new benchmarks in the arena of herbal products manufacturing, leveraging state-of-the-art infrastructure, skilled professionals, and uncompromised commitment towards quality and innovation.

Role : Manager QA

• To ensuring that the quality system is monitored, maintained and implemented.
• To comply with global regulatory guidelines.
• To approve and monitor Master document /Quality/Technical documents/Artwork, BMR,BPR,MFR, Validation Protocol/Report
• To Approve and monitor validation master plan, Site Master File, Specification-Raw and Packing Material, Intermediate/Bulk, Finished Product, Training Need Identification, Level-I, Level-II and Level-III documents
• To approve/reject Incoming material vendor/Outside testing lab/Calibration /Service contractor /Transport service provider and other GMP related outside contract activities.
• To review and approval of Standard Operating Procedure and other documents including amendments, Training and Implementation
• To approve/reject the incoming RM/PPM and SPM, intermediate stage product, finished product and control of manufacturing environment.
• To approve / suggest corrective action & preventive action (CAPA) or member of investigation team for complaint, recall, deviation, change control, OOS, validation, calibration, risk assessment, new or additional vendor, Query, APR, self-inspection report, non-conformity, batch release, reprocess, returned good etc if any in process and practices.
• To ensure the qualification and maintenance of department, premises and equipment;
• To carry out observation and risk analysis of critical product / process parameter
• To share investigation report with all supported data to the reporter.
• To be the part of all internal and external audits and respond to the audit observations.
• To Monitor all process validation related and technology transfer activities.
• To review and discuss with functional head for agreed commitment in draft quality agreement prior to approval.
• Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement
• To conduct training program on GMP/GDP/GLP/GEP/Technical/Procedural etc topics and identify training needs for department personnel and organize the same.
• To understand the method study & motion study of all the operation procedures for identifying areas of quality improvements.
• To attend Regulatory Affair (IRA) departments queries and work accordingly and to organize all needed the documents for regulatory submissions.
• To allocate, Assist subordinate to carry out job responsibility smoothly.
• To monitor retention of records.
• Set quality goals and objectives for the company and develop plans to meet those goals and objectives.
• To do budgeting of his department and ensure resource availability.
• To ensure the job specific training of department person and enhancement of role as per his capability.
• To ensure his/her roles and responsibilities in the absence of sub-ordinate
• To ensure the weekly and monthly report against activity.
• To approve / reject the leaves of the reporting members.
• To coordinating with QA, QC, production, engineering and warehouse team, Purchase, business, regulatory so as to manufacture product with quality attributes and in given timelines.
• Time to time communicates and escalation any failure or abnormal notification/critical observations /non-compliance/extraordinary observation to function head/ appropriate levels of management for their attention and progress report by taking plant round and review of random record.
• To communicate system enhancement or an improvement in exiting system to the management.