36 Ipqc Jobs

Role & responsibilities : 1.English Communication skills, 2.Good local launguage Communication Skills 3.Good Knowledge in Excel & PPT IQC Job Description: 1.Should know the Incoming quality control lab process in any EMS industry 2.Good knowledge about sampling plan and IQC control plan 3.Should know about inventory management and ageing control. 4.Have knowledge about conduct MRB meeting for rejection 5.Should know prepare the SOP & SIP and LRR. 6.Familiar with smartphones and process 7.should know about 5s/ESD/7QC tools knowledge 8.Should know the yield and production basic knowledge 9.Need manpower handling near 30x operators 10.Need strong knowledge on supplier quality process in EMS industry 11.Familiar to handle the suppliers domestic and international. 12.Strong knowledge about the 4m analysis and review the FACA 13.should know about 5s/ESD/7QC tools knowledge 14.Skill in yield and production process in EMS 15.Strong knowledge on vendor escalation and get corrective action PQC Job Description: • Responsible for Leading the Quality function and day to day In-process Quality verification with consistent result both in terms of Quality and Quantity to meet daily plant output/customer requirements. • Performing in-process quality inspection for accuracy, specification parameters and workmanship. Develop and implement best quality processes in production • Tabulate and document data relating to products, processes, materials, its qualities, and reliabilities. • Train staff, technicians, and professionals on the aspects of quality control activities. • Troubleshoot and resolve problems relating to quality using quality tools ( analysis of COPQ in order to achieve savings.DMAIC, 8D, 4Q, PDCA etc.) Capture and PDCAP-YY7 • Conducting regular Inspections and Audits to assess product quality and compliance with established standards. • Collaborating with production teams to Identify areas for improvement and develop solutions to address quality Issues. • Ensuring that all quality-related processes comply with local and international regulations and standards. • Providing training and support to production teams to improve their quality control skills and knowledge. • Reviewing customer feedback and using this information to identify areas for improvement. • Support during Customer Intections, QA drafting and approvals etc. Implementing Poka-Yoke wherever possible to prevent quality errors and improve safety level. • Support and lead continuous improvement programs, problem solving and process improvement activities. • Adhere to QMS, other company policies and procedures & Quality Documentation Control. • Strong Technical know-how about the Process flow. KAIZEN & ISO-9001 and 14001,45001 Documentation. • Strong Knowledge about the Corrective Action Plan (8D), Continual Process Improvement. • Shows moral courage, openness and honesty in all dealings. Good communication and interpersonal skill.

Opening in Medicamen Biotech Ltd(ANVISA & EU), Bhiwadi, Raj. Pharma formulation exp. Preferred Qualification: B.Sc./B.Pharma Vacant Post: 10 Nos. QA - IPQA/Documentation/Validation QC - IPQC/HPLC/Chemical Testing/GC/KF Mail-ID: hrd@medicamen.com Required Candidate profile Immediate joiner prefer Experience : 2 to 6 Years Ready to Relocate Bhiwadi Self Motivated/ Team Player/ Committed for Performance. E-Mail: hr-ho@medicamen.com Mob: +91 7240001632/ 9992395009

Complete analysis of Paddy & Rice - all varieties (Basmati & Non-Basmati).Sampling and analysis of rice during milling and packaging process to ensure that it meets with predefined criteria. Only from rice Industry Perks and benefits CANTEEN FACILITIES,BACHELOR ACCOMMODATION

Position Executive / Sr. Executive- QC Grade : A3 A4 Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to Lab In charge-QC; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling and Analysis. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities.; Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees Qualification and Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies; (Technical, Functional and Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument

Quality Management System: Oversight/Handling of Handling of Change Control, Incident / Deviation and CAPA. Following and tracking of Change Control, Incident /Deviation and CAPA. Involved in the investigation activity whenever required. Ensure that products are manufactured in compliance to Regulatory requirements and as per Good Manufacturing Practices. Ensure that production and manufacturing activities are undertaken in compliance to SOPs, systems, procedure and GMP/GLP requirements. Maintain GMP compliance in various departments to manage the production in line with the current GMP requirement. Handling of Change Control, Deviation, risk assessment and CAPA as per company procedure Verification & Follow-up of CAPA implementation as per provided target completion date. Involved in the handling of Market Complaints. Review of QMS documents. Vendor Qualification Activity: Oversight of Vendor Qualification related documentation. Planning and execution of the vendor Qualification activity with co-ordination with user department. Preparation and review of document related to Vendor Qualification. Execution of schedule / planned Vendor/Supplier Qualification as per the Protocol. Qualification/ Validation - Data compilation and Report preparation. Review and compilation of data generated in validation and qualification of vendors. Coordination with external agency for Qualification, validation, calibration and outside services related to Vendor Qualification. Qualification of External agency for Qualification, Validation and Calibration agency as per the SOP. Planning of the vendor audit as per requirement. Self-Inspection: Oversight of Self-Inspection program 4. Management and overall tracking of audit observation- Audit & Compliance (Internal and External audit). Oversight of IPQC & Microbiology Section: - Ensure in-process product and process related quality assurance activities (IPQA) are undertaken by IPQC team. Validation and Qualification Activity: Review of Validation and qualification related activities as and when required. Planning of the validation activity with co-ordination with user department.

Coordinating the daily operation and management of the QC team (OQC/, rationally arranging manpower supplements according to actual production schedules, and improving work efficiency. Required Candidate profile Engineering quality tools, Problem solving tools, 8D, 6Sigma, SPC and other quality tools. Core tools knowledge ERP/ SAP/ Oracle hands on experience Master the skills , Minitab, email etc.

Handling customer complaints Lead customer audits Lead engineering change management NPILead team & quality risk controlling Participate Process quality abnormality handling, control quality risk points, and promote quality improvement Required Candidate profile Proficient in quality negotiation & crisis quality incident management, product failure analysis, Engineering quality tools Abilities: Problem solving, customer handling, Communication skills

Roles and Responsibilities Perform quality control checks on electronic components and semiconductors using SMT process, THT/PTH process, Surface Mount Technology, IPQC, and Inprocess Quality techniques. Conduct regular inspections to ensure compliance with industry standards and company policies. Identify defects or anomalies in products and report them to relevant teams for rectification. Collaborate with production staff to resolve issues related to product quality. Maintain accurate records of testing results and inspection reports. Desired Candidate Profile 1-3 years of experience in electronics manufacturing or a related field (diploma holders preferred). Strong understanding of electrical engineering principles and practices.

Department: Quality Control Location: Tehsil Inodra, Kangra (HP). Near by Pathankot Reporting to: QC Manager / Head Quality Department Key Responsibilities: Conduct routine testing of raw materials, in-process materials, and finished products as per approved specifications and standard test procedures (STPs). Perform chemical and instrumental analysis using HPLC, UV, IR, GC, KF, etc. Maintain accurate and up-to-date laboratory records, worksheets, and logbooks. Ensure timely calibration and maintenance of laboratory instruments and equipment. Review and follow Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Assist in method development and method validation activities as required Conduct stability testing and prepare stability summary reports. Ensure compliance with company SOPs, quality standards, and regulatory requirements (such as USFDA, MHRA, WHO, etc.). Participate in internal and external audits and implement corrective and preventive actions (CAPA). Manage sampling, labeling, and storage of test samples as per SOPs. Handle out-of-specification (OOS), out-of-trend (OOT), and deviations according to quality procedures. Coordinate with production, QA, warehouse, and other departments for quality-related issues. Monitor environmental conditions of the lab as per the standard protocol. Desired Candidate Profile: Education: B.Pharm / M.Pharm / B.Sc / M.Sc Chemistry or related field Experience: 2–10 years in QC role within a pharmaceutical formulation plant Skills Required: Proficient in operating analytical instruments (HPLC, GC, etc.) Knowledge of GMP, GLP, ICH guidelines Strong documentation and communication skills Attention to detail and ability to work under pressure Good analytical and problem-solving skills

Role & responsibilities Kindly share the updated resume, If already shared then Reply back that you are Interested for the role and that you will attend the interview. Role Overview: The Senior Manager / Manager - Quality will be responsible for ensuring the highest quality standards across manufacturing processes, supplier quality, and finished products. The role requires expertise in Six Sigma, Lean Manufacturing, and Process Quality to drive continuous improvement and operational excellence. The individual will lead quality initiatives, implement best practices, and collaborate with cross-functional teams to maintain product integrity and customer satisfaction. Key Responsibilities: Quality Strategy & Implementation: Develop and execute a comprehensive quality strategy aligned with business goals. Process Quality Management : Drive process improvements using Lean, Six Sigma, and other quality methodologies to enhance efficiency and reduce defects. Supplier Quality Assurance: Establish robust supplier quality control mechanisms to ensure consistent raw material and component quality. Manufacturing Quality: Implement best practices in quality control and assurance to ensure defect-free production and compliance with industry standards. Continuous Improvement: Lead initiatives to enhance manufacturing excellence, reduce waste, and optimize production processes. Root Cause Analysis & Corrective Actions : Investigate quality issues, implement corrective and preventive actions (CAPA), and ensure problem resolution. Regulatory & Compliance: Ensure compliance with industry regulations, certifications, and internal quality standards. Team Leadership: Mentor and lead the quality team, fostering a culture of quality excellence and continuous learning. Customer Focus: Analyze customer feedback, address quality-related concerns, and drive improvements to enhance customer satisfaction. Certifications: Six Sigma (Black Belt/Green Belt), Lean Manufacturing, or equivalent certifications preferred. Skills: Strong expertise in Lean, Six Sigma, and quality management systems. Experience in supplier quality management and vendor audits. Proven track record of leading process quality improvements and waste reduction initiatives. Ability to drive change, implement best practices, and influence cross-functional teams. Strong problem-solving, analytical, and decision-making skills. Excellent communication and leadership abilities Thanks & Regards, Jensy, Email: recruiter@apmcindia.in Contact.No: 9585586622

Roles and Responsibilities Conduct quality audits, inspections, and reviews to ensure compliance with industry standards and company policies. Identify areas for improvement through root cause analysis (RCA) and implement corrective actions using tools like Poka Yoke, Capa, and Kaizen. Develop and maintain documentation related to quality control processes, including procedures, checklists, and reports. Collaborate with cross-functional teams to resolve issues related to product defects or non-conformities. Desired Candidate Profile 3-8 years of experience in a manufacturing environment with expertise in 7QC, 5S, IPQA/IPQC, IATF 16949:2016 certification. Strong understanding of QC tools such as Vernier caliper, Micrometer, Height gauge; rejection analysis; reject handling process. Proficiency in MS Office applications for document preparation and record-keeping. Regards Aadhya Agrawal 8439753001

Role & responsibilities Candidate have basic knowledge of quality check and OBA Candidate have knowledge of electronics components Candidate should be able speak and write in English . Preferred candidate profile

Role & responsibilities Manage timely delivery of feed tank to HCM with compliance to IPQC parameters and supervises all resources (raw material, equipment, manpower) and activities in a shift. This will be in-line with the schedule prepared by the In-charge for that day. Execute the shift activities (MM Charging, review FT planning, shift manpower deployment) allocated to him as per the plan Ensure shift handover/takeover on the shop floor and hold accountability for any failures/challenges in the previous shift. Review the dipping schedule daily to prioritize the FT preparation schedule, color change, ZMICs for specific requirements for all upcoming batches and highlight the necessary corrections to FT Chemist/operator Monitor various parameters such as shade, bubbles, viscosity, solution temperature & SCADA monitoring at regular intervals as per defined Verification of dip bath and FT cleaning as per SOP to avoid non-compliance wrt GMP Preferred candidate profile Education : B.Pharmacy/M.Pharmacy, B.sc/M.sc (Microbiology), (Chemistry) Experience : Atleast 4 years in capsules/pharma industry Preferred Industry : Capsules Manufacturing Preferred Qualification : FDA Approved Perks and benefits

Lead QA Dept handling GAUGE INSTRUMENTS QUALITY PLANNING, INSPECTION METHODS, RAW MATERIAL APPROVAL PROCESS, NCR CLOSURE, RJECTION ANALYSIS, CUSTOMER QA, CUSTOMER COMPLAINTS ANALYSIS, SUPPLIER PERFORMANCE MONITORING, QMS (ISO9001, AS9100 & ISO14001.. Required Candidate profile BE 15+yrs exp into QA 5+yrs exp with AEROSPACE UNIT must Strong in IPQC, SQA, CUSTOMER QA & QMS Strong exposure in FAI related activites, NADCAP, GD&T, CMM Call Prabhu @ 7010863499 AEROSPACE exp must Perks and benefits Excellent Perks. Send CV recruiter@adonisstaff.in

Quality Assurance Leadership, Compliance Oversight: Ensure all processes comply with cGMP, ICH, and other relevant regulatory requirements, Process Improvement: Identify and implement continuous improvement initiatives to enhance product quality .

Key Responsibilities: Conduct in-process inspection of injection moulded parts as per control plan/specifications Monitor and record process parameters and part quality at defined checkpoints Identify and report any non-conformities during production Ensure product compliance with SOPs, drawings, and quality standards Support line clearance and batch changeovers Maintain inspection records, test results, and rejection reports Coordinate with production and QA for defect resolution

KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided

IQC (Incoming Quality Control) SQA (Supplier Quality Assurance) IPQC ( In Process Quality Control) Strong SMT Components Knowledge Must

We are Hiring for IPQC Production Analyst for our client company for Taloja location Job description- Looking for 3+ year experience IPQC Production Analyst is responsible to operate the working of the plant Inprocess testing lab section in AP Liquid & AP Dry Dept (powder processing / packing & labelling sections) at Taloja plant in shifts.The person shall execute the inprocess product quality testing and should adhere to regulatory compliance by maintaining quality systems and current Good Manufacturing Practices (cGMP). The person shall be ready to handle the troubleshooting of laboratory instrument and shall be responsible to work in shifts based on requirements Role & responsibilities This person will have to understand the AP Liquid and Dry Dept procedure. Responsible for performing chemical / physical parameter inprocess testing using analytical instruments like Analytical Balance, Malvern Particle Size Analyzer, Chloride titrator, Density meter, Auto titrator etc. He Should have experience or the ability to learn troubleshooting of laboratory instrument and making simple repairs as needed. He should be familiar with the workings of a regulated environment like GLP, cGMP, GDP, ICH Q7A, etc. Responsible for completion of all Inprocess testing lab documentation in timely manner. Responsible for performing the investigation for Inprocess testing lab laboratory failures, if any Report proper safety precautions with respect to himself and others, including company property. Responsible to do any other production / quality related work assigned by the reporting manager and management. Responsible for performing in-process testing on the instrument and legibility and accuracy on all paperwork. Responsible for understanding aspects of the spray drying, milling, and screening operation. This includes starting up, shutting down, and making process changes to maintain quality. Responsible for the adherence of safety procedures with respect to chemicals handling in plant / lab during shift operations. The incumbent will be responsible for the safety of the contract labor allotted to him. Ensure proper functioning of Inprocess testing lab instruments and immediate reporting of breakdowns for rectification, if any. Responsible for adherence to SOPs for all Inprocess testing lab / plant operations, maintaining good housekeeping in plant / lab. Filling online documents during shift and understanding of unit operation & unit process. Responsible for understanding of production requirements to achieve production target. Responsible for understanding of MSDS of different chemicals used in Inprocess testing lab. Responsible for filling of documents for activities performed. Looking for candidates who can join immediately or within 20 days.

Quality Control Documentation & Procedures: Create and update quality control documentation and procedures to ensure compliance and reflect industry best practices. Regularly review to keep protocols current. Lead Customer and IMS Audits: Conduct and manage customer and IMS audits, ensuring adherence to standards and promptly addressing any issues. Use audit feedback to drive continuous improvement. Real-Time Data Migration: Oversee the migration of electrical data and IV graphs to the cloud, ensuring accuracy and timeliness. Resolve any data migration issues swiftly to maintain system integrity. Calibration Module Availability: Ensure calibration modules are available and functioning properly through regular maintenance and calibration. Coordinate with teams to prevent production delays. Training and Development: Develop and deliver training on calibration and quality control, incorporating industry advancements to enhance staff skills and compliance. Promote continuous learning. Documentation and Reporting: Prepare and maintain reports on calibration and audit activities, ensuring timely and accurate documentation. Provide insights on performance metrics to support decision-making. Key Stakeholders - Internal: Calibration Team Quality Assurance Managers Maintenance Team Production Managers Key Stakeholders - External: Calibration Service Providers Certification Agencies Regulatory Bodies Suppliers

Handle both INPROCESS QUALITY & SUPPLIER QA handling LINE QA, REJECTION CONTROL, ZERO REJECTION, CALIBRATION, CHILD PARTS INSPECTION, SUPPLIER QUALITY, SUPPLIER AUDIT, NPD, PART DEVELOPMENT, SUPPLIER HANDLING, SUPPLIER ASSESSMENT, SUPPLIER EVALUATION Required Candidate profile Only BE 5+yrs exp with EMS/AUTO Electronics into IPQC and SQA handling LINE QA, REJECTION CONTROL, CALIBRATION, SUPPLIER QUALITY, SUPPLIER AUDIT, SUPPLIER ASSESSMENT Exp with ElMS/ Auto EMS unit must Perks and benefits Excellent Perks. Send CV cv.ch2@adonisstaff.in

Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;; Reports to Lab In charge-QC Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL . Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling and Analysis. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees Qualification and Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional and Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument

Dear Job Aspirants, Mega Hiring Event from India's Biggest I-Phone Manufacturer located in Hosur, Tamil Nadu. Are your an experienced Engineer / Diploma holder from Electronic Manufacturing Services industry (Mobile Phone component manufacturing / Mobile Phone Assembly) We have 1000+ Job opportunities from multiple departments in EMS industry. Kindly Share your resume to murali.manoj@aramhiring.com with email Subject as "EMS Profile", we will get back to you with your interview date and interview slots. Important Note: Hiring only 3+ years experienced candidates, fresher kindly do not apply for this role. Different Positions Available in EMS Industry: 1) SMT ( Surface Mounted Technology) - Production, Process, Engineering 2) Production - production, Repair Engineering, Failure Analysis 3) Process - NPI, Quality, Process Engineering 4) Engineering - Equipment Engineering, Manufacturing Engineering, Automation Engineering, Failure Analysis Testing 5) FATP - (Final Assembly Testing & Packing) Manufacturing Engineering, Automation Engineering, Failure Analysis Testing, De-Bugging and Repairs 6) MLB - (Multi Layer Board)Automation Engineering, Process Engineering, Equipment Engineering, Testing 7) Quality : IQC, OQC, IPQC, SQM, SMT QC, ORT 8) SCM : Purchase, Stores, Logistics Salary & Benefits: 1) Best Salary in the industry based on your last drawn salary and relevant work experience 2) World class Employee benefits - Transportation, Accommodations, Food, life care and much more 3) Job security in working for India's biggest brand and periodic financial and designation growth What are your waiting for, kindly share your resume to murali.manoj@aramhiring.com with an email Subject as "EMS Profile", we will get back to you with your interview date and interview slots. Important Note: We are hiring for multiple companies, please write an email with email subject as "EMS Profile". Regards, Murali Director HR - Aram Hiring Solutions

Dear Job Aspirants, Mega Hiring Event from India's Biggest I-Phone Manufacturer located in Hosur, Tamil Nadu. Are your an experienced Engineer / Diploma holder from Electronic Manufacturing Services industry (Mobile Phone component manufacturing / Mobile Phone Assembly) We have 1000+ Job opportunities from multiple departments in EMS industry. Kindly Share your resume to murali.manoj@aramhiring.com with email Subject as "EMS Profile", we will get back to you with your interview date and interview slots. Important Note: Hiring only 3+ years experienced candidates, fresher kindly do not apply for this role. Different Positions Available in EMS Industry: 1) SMT ( Surface Mounted Technology) - Production, Process, Engineering 2) Production - production, Repair Engineering, Failure Analysis 3) Process - NPI, Quality, Process Engineering 4) Engineering - Equipment Engineering, Manufacturing Engineering, Automation Engineering, Failure Analysis Testing 5) FATP - (Final Assembly Testing & Packing) Manufacturing Engineering, Automation Engineering, Failure Analysis Testing, De-Bugging and Repairs 6) MLB - (Multi Layer Board)Automation Engineering, Process Engineering, Equipment Engineering, Testing 7) Quality : IQC, OQC, IPQC, SQM, SMT QC, ORT 8) SCM : Purchase, Stores, Logistics Salary & Benefits: 1) Best Salary in the industry based on your last drawn salary and relevant work experience 2) World class Employee benefits - Transportation, Accommodations, Food, life care and much more 3) Job security in working for India's biggest brand and periodic financial and designation growth What are your waiting for, kindly share your resume to murali.manoj@aramhiring.com with an email Subject as "EMS Profile", we will get back to you with your interview date and interview slots. Important Note: We are hiring for multiple companies, please write an email with email subject as "EMS Profile". Regards, Murali Director HR - Aram Hiring Solutions

Position Assistant Manager - Quality Control Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to QC Head; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory and Pharmacopeia requirement for lab compliance. Review of hybrid and electronic data for IPQC and FG analysis.; Analytical method validation, OOS and OOT.; Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Resolve the trouble shooting related to QC activities.; Training to subordinate and employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab. Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees 2-3 numbers Qualification and Experience M.Sc. (Chemistry) with 8-12 yrs. y Competencies; (Technical, Functional and Behavioral) Responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. Hand-on experience as Reviewer of electronic data and hybrid system in regulatory environment (US-FDA, WHO etc.) Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)