WE INVITE APPLICATIONS FOR OPERATIONAL EXCELLENCE Experience: 06 to 08 years Key Responsibilities of the Position: Required core Pharma industry Experience only. Operational Excellence and Continuous Improvement Lead and implement Lean Manufacturing, Six Sigma, TPM, and Kaizen initiatives to drive continuous improvement. Identify and eliminate process bottlenecks to enhance efficiency, productivity, and cost-effectiveness. Conduct RCA, FMEA and Risk Assessments to improve operational reliability. Ensure OEE improvement, cycle time reduction, and waste minimization. Develop and monitor KPIs for process efficiency, cost reduction, and quality improvement. Conduct Gemba walks and Value Stream Mapping to identify improvement opportunities. Optimize workflow, space utilization, and operational efficiency through layout modifications. Support automation and digital transformation initiatives to enhance manufacturing performance. Implement risk mitigation strategies for critical processes and equipment failures. KPI Monitoring and Ensuring Business Impact Define and Monitor Key Performance Indicators, including: Manufacturing efficiency and productivity Quality and Compliance performance Reliability and Maintenance effectiveness Supply chain and Inventory Optimization Financial Impact and cost optimization Employee productivity and Continuous improvement engagement Data driven decision making & reporting Develop and maintain dashboards using ERP, and Business Intelligence Tools (Looker Studio, Power BI, etc.). Perform RCA for any KPI deviation and implement corrective measures Collaborate with finance, quality, production, maintenance & supply chain to align KPI goals with overall business objectives Generate monthly and quarterly reports for senior leadership, highlighting the trend, risks and action plans. Qualifications and Experience Required: Educational Background: Bachelor’s degree in Engineering (Mechanical, Industrial, or related fields) Certification in Lean Six Sigma (Green/Black Belt) Professional Experience: 6-8 years of experience in pharmaceutical injectables manufacturing, operational excellence, or process improvement Strong background in Lean Manufacturing, Six Sigma, and Continuous Improvement initiatives Experience in process improvement, plant layout optimization, and capacity expansion projects Proven ability to lead cross-functional teams, drive efficiency, and implement cost-saving initiatives Experience in ERP systems and other manufacturing digital tools. Languages – English, Gujarati We wish to have association with people like you in our organization and you may confirm your interest by sending your detailed resume on hr@swiss.in Job Location Ahmedabad HR Department 99789 76432 Website : www.swiss.in Show more Show less
Department: Production QMS Designation: Officer to Executive Experience: 3 to 6 Years Location: Bavla, Ahmedabad 🔹 Key Responsibilities: ✅ Injectable Production Activities Carry out and monitor day-to-day manufacturing of injectable products (aseptic or terminal sterilized). Follow batch manufacturing records (BMRs) and SOPs during production. Coordinate with cross-functional teams like QA, QC, and Maintenance for smooth operations. ✅ Quality System Support Handle QMS activities such as deviations, CAPA, change control, and documentation updates. Participate in investigation and closure of production-related quality events. Assist in risk assessments and implementation of preventive actions. ✅ Compliance & Documentation Ensure proper documentation of all production operations. Adhere to data integrity and good documentation practices (GDP). Support SOP revisions and ensure they reflect current practices. ✅ Audit Readiness Assist in preparation for internal and external GMP audits (USFDA, EU, WHO, etc.). Ensure compliance with cGMP, regulatory requirements, and company standards. ✅ Training & Improvements Conduct or attend GMP and QMS training sessions. Suggest and implement improvements to increase process efficiency and quality. Must Exposure in Parenteral Background We wish to have association with people like you in our organization and you may confirm your interest by sending your detailed Resume on Recruitment@swiss.in
Department: Production ( Injectable ) Designation: Assistant Manager Experience: 7 to 10 Years Location: Bavla, Ahmedabad Education: M. Pharma, B. Pharma, M. Sc Job Description: To Follow the growing procedure during and exit in clean room, manufacturing and in autoclave area. To Follow the personal hygienic and clean room behavior in the production area. To responsible For All type of activity performed in dispensing and manufacturing area. Before dispensing reverification of calculation of API and ensure same to be reverified by IPQA. To Ensure the dispensing Of API and Excipients is as per respective BMR and Related SOPs. To reverify the dispensed API before Start of Manufacturing Operation. To Check and performed the CIP and SIP of Manufacturing tank to use for Manufacturing and holding of batch. To check the calibration and qualification status of tank before start of manufacturing. To take the line clearance form IPQA Before start of manufacturing operation. To Complete of documents Of Ongoing operations in Dispensing and Manufacturing Area. To Inform to Production Manager for Dispensing and Manufacturing related activities. To ensure the area monitoring, cleaning & Sanitization of all classified and non- classified area, temperature & %RH Monitoring in all production area. To Follow the clean room behavior in aseptic area and to train the people who area working in classified area about aseptic area behavior and aseptic practice. To perform dispensing and manufacturing of products as per procedure mentioned in BMR. To operate the Manufacturing vessel in manufacturing area as per defined procedure. To inform the Production Manager for breakdowns if any and to intimate the engineering department through defined procedure for breakdowns if any. Ensure to send the wash water during product change or batch change as per defined in SOP. To check and control all critical parameters during batch manufacturing. To make entry in Pharma Cloud software as per production activity. To intimate the IPQA personnel to collect and send. the bulk sample to QC at the end of batch manufacturing. To do online documentation in logbooks and BMR. To prepare and review of SOP of Production area as per regulatory and CGMP requirements. Prepare and revised the BMR for new and existing products. To co-ordinate with dispensing area personnel for the dispensing of raw materials. To co-ordinate with filling area personnel for their filtration of product solutions. To intimate QC department for bulk testing of product in advance. To co-ordinate with QC department for bulk testing. To co-ordinate with QA department for line clearance related activity, Qualification, Validation and Media fill related activity. To co-ordinate with engineering department for routine maintenance and preventive maintenance related activity. To implement continuous improvement for all production activity as suggested. To participate in execution of qualification and validation activity in accordance with QA and Engineering department. To give awareness and SOPs training to the the personnel working in Dispensing and manufacturing area To prepare requisition slip for outside maintenance 'work of machine or machine parts. Do all other work given by management as and when required. Ensure to always follows the safety norms of plant. *Transportation and Canteen Facility Available. Regards, Pruthviraj Mandora 6352978952 E- mail :- Recruitment@swiss.in URL :- www.swiss.in
Department: Quality Assurance (Process Validation, Qualification ) Designation: Officer / Executive Experience: 2 to 6 Years Location: Bavla, Ahmedabad Education: M. Pharma/ B. Pharma/ M. Sc Job Description: ( Process Validation ) To prepare standard operating procedure. Issuance of controlled Format to concern department. Provide the required documents to regulatory for dossier submission. Follow – up with concern department to complete the documentation. To prepare protocol for Process Validation, cleaning validation and hold time validation study. To execute process validation, hold time validation and cleaning validation activity and co-ordination with all departments for planning. Review of protocols for process validation, cleaning validation and hold time validation Preparation and communication of critical process parameters based on process validation study Preparation and communication of hold time to production based on obtained hold time study reports. Sample collection, submission, report compilation and preparation of summary report for process validation, cleaning validation and hold time validation. Issuance of Hold time Validation, cleaning validation and Process Validation Protocol. Any other work assigned by HOD. Job Description: ( Qualification ) Qualification of Equipment/system such as HVAC System, Autoclave, Bung Processor, Powder Filling and Sealing machine, Vial washing machine, Depyrogenation tunnel, Hot air oven, various Equipment. To prepare, review and execute protocol and report of validation for critical manufacturing processes like hold time, process validation, cleaning validation and media fill including observation of the media fill vials/ampoules etc. To Prepare, review and fill the IQ, OQ, PQ document of new Equipment/machine. Develop, Implement, manage, audit and maintain GMP Quality system. Review and approval of SOPs and other documentation related to the activities Participating in internal audits, for cause inspections etc. To review and check the QA SOPs and provide training before SOP implementation. To review another department SOPs. To review & approval of Master Documents like BMR, Protocols and Reports etc. Approve and release the final products or reject defectives. To Prepare SOPs, Protocol and Report related to all Qualification and Validation studies. Monitoring during calibration of various instruments. Follow the Qualification schedule to plan, execute and documentation. Performing the Temperature mapping activity of Manufacturing and staging area, Row Material storage area, Finished Goods area (NMT 25°C) and Cold Chamber (2°C to 8°C). To perform the new equipment/machine qualification (IQ/OQ/PQ). Prepared, review and filled the IQ, OQ, PQ document of new Equipment/machine. Review and approval of SOPs and other documentation related to the activities Participating in internal audits, for cause inspections etc. Understand customer needs and requirements to develop effective quality processes Responsible to maintain the plant hygiene. Vendor audit to the site for raw material and packing material supply, site evaluation, audit report preparation, vendor documents pack verification and final approval to include vendor in approved vendor list. Must Exposure in Parenteral Background We wish to have association with people like you in our organization and you may confirm your interest by sending your detailed Resume on Recruitment@swiss.in