45 Gdp Jobs

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD – Manufacturing / QMS (Senior Officer / Officer / Executive) Experience - 02 to 07 Years Qualification – B. Pharmacy/ M Pharmacy Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification – BE / B Tech Time and Venue : 14th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Job Title: Officer/Senior Officer Location: Ankleshwar Experience: 2-5 Year Department: Production Role and Responsibilities: Production Operations Check labels and verify identity of raw materials, packing materials, and solvents before use. Maintain appropriate storage conditions for raw materials and intermediates in the plant. Execute batch processes as per approved Batch Production Records (BPRs). Follow instructions from Shift In-charge or Production Manager for batch charging and monitoring. Monitor and maintain process parameters during manufacturing. Complete allocated tasks within the stipulated timeline with accuracy. Ensure contamination-free production and proper packing/repacking of materials. Adhere to proper gowning, hygiene, and entry protocols for classified production areas. Operate plant equipment and utilities safely and efficiently. Maintain cleanliness and proper segregation in the production area as per SOP. Documentation & SAP & GDP Perform online documentation of BPRs, cleaning logs, and equipment usage records during the shift. Maintain differential pressure, centrifuge bag records, and other PP/Intermediate area logs. Update SAP transactions for material consumption, yield recording, and inventory movements. Ensure timely entries in equipment logbooks and SAP-based process entries . Label all process equipment, HDPE/fiber drums, and accessories correctly per batch and SOP requirements. Ensure Good Documentation Practices (GDP) by making real-time, legible, complete, and traceable entries in all logs and records. GMP & Compliance Guide and train workmen on cGMP practices and technical SOPs. Ensure finished product yield and quality meet predefined specifications. Participate in internal audits, regulatory inspections, and SOP reviews. Perform calibration of instruments such as weighing balances and pH meters. Keep equipment status boards updated and follow QMS standards. Safety & Environmental Compliance Understand MSDS of all materials handled and ensure safe handling practices. Supervise plant operators to ensure chemical and equipment handling safety. Use scrubbers and proper exhaust systems to control emissions and avoid air pollution. Coordinate with the EHS department for required safety permits and compliance. Wastage Reduction Prevent solvent/material spillage and reduce wastage through proper process control. Ensure utilities (valves, pumps) are turned off when not in use to conserve resources. Cross-Functional Coordination Coordinate with QC for sample analysis and batch release. Liaise with engineering for breakdown and preventive maintenance activities during shift. Work closely with Warehouse, QA, and EHS departments for smooth operations. Interested candidate can share there cv at meet.chauhan@cadilapharma.com .

For Production Incharge : @ Post Graduate Profile only considered (MSC Chem) @ Shift handling @Shift planning @Documents review during shift. Production Operator/ Chemist. @Should follow Gmp @ Should follow documents.

Role & responsibilities To manage and oversee all store operations in a pharmaceutical manufacturing environment while ensuring efficient inventory control, proper documentation, and seamless material flow using SAP. 1. Inventory & Material Management: Oversee receipt, storage, issuance, and dispatch of raw materials, packing materials, consumables, and engineering spares. Maintain accurate inventory records and ensure optimal stock levels to avoid shortages or overstocking. Conduct regular cycle counts and physical stock verifications. 2. Regulatory Compliance & Documentation: Ensure strict adherence to GMP, GDP, and SOPs related to material handling and documentation. Maintain proper documentation for all material movements (e.g., GRNs, issue slips, return notes) as per regulatory standards. Handle audits from regulatory authorities and ensure compliance. 3. SAP System Management: Manage all store transactions in SAP (MM module), including goods receipt, goods issue, stock transfer, and inventory adjustments. Generate MIS reports for stock analysis, expiry tracking, and consumption trends using SAP. Coordinate with IT and SAP support teams for system improvements and troubleshooting. 4. Team Leadership & Coordination: Lead and mentor a team of store personnel, including allocation of duties, performance management, and training. Coordinate with Quality Control, Quality Assurance, Production, Purchase, and Planning departments for seamless material flow. Drive continuous improvement in store processes and layouts to enhance efficiency. 5. Safety & Housekeeping: Ensure proper storage conditions as per pharmacopeial and regulatory requirements (temperature, humidity, segregation). Implement and enforce safety measures for handling and storing hazardous materials. Maintain high standards of cleanliness and organization in the storage areas. *In addition to the above you may be given additional responsibilities as per business requirement and your JD can be altered at the discretion of your superiors. Years of Experience 18 25 years of experience, Proven track record of SAP-based inventory management and documentation. Strong knowledge of pharmaceutical GMP, GDP, and warehousing best practices. Familiarity with documentation requirements for regulated markets. Qualification Graduate in Science/Pharmacy/Commerce (B.Sc./B.Pharm/B. Com) Additional certifications in materials management or SAP (preferred)

*Must be aware of the working conditions in an API/Intermediate unit *Monitoring production planning to meet production target & ensure that the production records are maintained at the time of performance *Knowledge of GMP & GDP procedure to follow Required Candidate profile * Able to handle glass assembly 20L, 50L, 100L, 200L, 300L & Centrifuge 24’’ & 36’’ * Having exposure of handling CF, multi mill, Nutseh Filter, Blender, Shifter * Equipment handling

Key Roles/Responsibilities: Method Development of different drug product Routine analysis of development samples and lab stability samples GMP batch analysis, Stability batch analysis and reporting Peer review for the routine experiment PDLIMS data entry Analysis of raw material and packaging material Validation of analytical methods Calibration and maintenance of analytical instruments Preparation of tentative test procedures for routine development analysis, method development, method validation report and standard test procedure Follow GxP (GMP, GDP etc) for all processes Following in-house compliance system Maintain hygienic condition in respective department. Ensure use of Personal Protective Equipment & attend EHS training & send waste to concerned person & comply EHS requirements Refrigerator temperature monitoring and maintenance. Ensure data integrity Qualifications M.Sc. (Analytical Chemistry)/ M.Pharm (Quality Assurance/Pharmaceutical Analysis)

Role & responsibilities Handle Customs clearance, liaising with customs brokers and ensuring compliance with customs tariffs, taxes, and pharmaceutical regulations. Ensure that all necessary documentation (e.g., invoices, packing lists, certificates of origin, import permits, etc.) is accurate, complete, and in compliance with customs and regulatory requirements Coordinate the end-to-end import process for input material and CAPEX goods, ensuring timely shipment clearance from ports and on time delivery in warehouse. Supporting Courier import and export clearances for manufacturing plants Should have experience in Food Industry Preferred candidate profile Bachelors degree in Logistics, Supply Chain Management, International Business, or a related field. Minimum of 5 years of experience in logistics, import/export operations, or supply chain management, preferably within the Food or Non Food sector. Knowledge of pharmaceutical industry-specific regulations, such as Good Distribution Practice (GDP), cold chain management. Familiarity with import documentation, customs procedures, and tariff classifications. Proficiency in Microsoft Office (Excel, Word, PowerPoint) and knowledge of logistics management software (e.g., SAP, Oracle, or similar systems). Location : Kodambakkam Chennai Email : Chandramouli.r@sodexo.com

Location: Gandhinagar, Gujarat (On-site) Job Title: Quality Control (QC) Engineer Position Details Department: Quality Control Reporting To: Senior QC Engineer Working Days: 6 days/week Industry Preference (Mandatory) Applicants must have prior work experience in at least one of the following regulated manufacturing sectors: Sterile/Injectables Manufacturing Medical Devices Manufacturing Medicinal Equipment Manufacturing Position Overview We are looking for a proactive and detail-driven Quality Control (QC) Engineer with 3- 5 years of experience in Sterile/Injectables, Medical Devices, or Medicinal Equipment manufacturing environments. This role is critical to ensuring consistent product quality through comprehensive analytical testing and adherence to stringent regulatory standards. The ideal candidate will have hands-on expertise in chemical analysis, pharmacopeial testing, and GMP-compliant documentation, especially within a sterile or cleanroom environment. Key Responsibilities Conduct routine testing of raw materials, in-process samples, and finished products in accordance with pharmacopeial guidelines (IP/BP/USP/Ph. Eur.). Perform detailed Pharma Copea Testing including identification, assay, dissolution, impurity profiling, and other analytical parameters. Execute general wet chemistry procedures along with pH and conductivity testing . Operate and calibrate analytical instruments including IR Spectroscopy , STIR , and related chemical analysis equipment. Ensure strict compliance with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and internal Standard Operating Procedures (SOPs) . Maintain complete and accurate documentation including test reports, calibration records, instrument logs, and change control records. Support investigations related to Out of Specification (OOS) and Out of Trend (OOT) results, including root cause analysis and CAPA. Liaise with Quality Assurance (QA) , Production , and R&D teams for resolution of analytical issues and technical support. Prepare for and participate in internal and external audits, ensuring full laboratory compliance and readiness. Manage sample collection, labeling, storage, and contribute to stability studies where applicable. Candidate Requirements Educational Qualification (Preferred): B.Sc / M.Sc in Chemistry B.Pharm / M.Pharm with a focus on Pharmaceutical Chemistry Experience: 3- 5 years of relevant experience in a pharmaceutical or regulated manufacturing environment Must have worked in Sterile , Injectables , Medical Devices , or Medical Equipment manufacturing Technical Skills: In-depth knowledge of pharmacopeial testing methods and documentation practices Hands-on experience with IR Spectroscopy, STIR, pH meters, and conductivity meters Familiarity with analytical method validation and instrument calibration Strong understanding of Data Integrity , GDP (Good Documentation Practices) , and compliance in regulated cleanroom settings

Role & responsibilities Job responsibilities for a Senior Executive in Instrumentation lab at Hetero Plasma Sciences, with 5-6 years of experience in Quality Control department. Operate, maintain and troubleshooting of HPLC, Gas chromatography (GC), UV Spectroscopy and Kjeldahl system for various analytical applications. Good Laboratory Practices: Ensure all laboratory activities comply with GLP standards, maintaining high-quality and reliable results. Good Documentation Practices (GDP): Maintain accurate and thorough documentation of all analytical procedures, results, and maintenance activities Method validations: Execution of method validations as per protocols, documenting and ensuring compliance with industry standards. Manage and oversee laboratory operations across different shifts, ensuring continuous and efficient workflow. Coordinate with team members to ensure smooth transitions between shifts and maintain consistent quality of work. Handling of Plasma products experience is preferable.

Role & responsibilities Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site. Vendor complaints: Handle vendor complaints at site for getting actions closed at site & with suppliers for on time closure. Training: Ensuring completion of site trainings as per training calendar at site. Work with Site "Education & Training Lead" to improve site training program (e-Learning). Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software.

Key Roles & Responsibilities : The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software. Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern P&G Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site.

A. Job Objective Monitor and review In Process quality control checks to meet the required quality compliance as per specifications. Strategic and planning Functional Core:- Review and provide decision based on the IQC sheet Online feedback to production for correction Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same. Monitoring CAPA during shifts. Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same. Track instance of repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR. Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System Ensuring document verification generated during shift on daily basis against defined standards Internal process Preparation of various reports Maintenance and verification of gauges to ensure proper calibration of these equipments on a regular basis in each shift Ensure verification of shade against master and Macbeth report Verification of daily profiles and online graphs Periodically conduct process, product and systems Audit. To provide data for annual product quality review & Participate in APQR and finalise the recommender's People development Ensure proper manning and shift handling, shift activities. Effective training to the operators with evaluation for compliance. Effective manning to utilization of available sources.

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

Role & responsibilities strong C++ Developers UNIX experience is mandatory for efficiency • Excellent Coding experience . • Debugging Mandatory and GDP experience to be evaluated • Oracle – good to have • The team will be soon shifting to Cloud Environment, so cloud exposure is good to have • Majorly looking for Application Development , Enterprise experience side of C++ • C++ 17 – preferable • Candidates should have understanding about C++ concepts and Design Thinking • They need candidates who can be onboarded immediately

Role & responsibilities strong C++ Developers CTC will be same UNIX experience is mandatory for efficiency • Excellent Coding experience . • Debugging Mandatory and GDP experience to be evaluated • Oracle – good to have • The team will be soon shifting to Cloud Environment, so cloud exposure is good to have • Majorly looking for Application Development , Enterprise experience side of C++ • C++ 17 – preferable • Candidates should have understanding about C++ concepts and Design Thinking • They need candidates who can be onboarded immediately

Hi, Greetings from Datamundi.ai! We got your Profile from Naukri, as We have a full-time contractual job opening for Guidewire Developer Please find below Job description: Role: Guidewire Developer Languages : English Experience: 3-8 years Timings: 9:30 AM 6:30 PM (General Shift) Duration: On going (6 months under the payroll of Datamundi.ai (probation), May extend based on project progress and performance) Location: Bangalore, Client's Office (Exact location will be confirmed post interview) Budget: 10 LPA Interview Process: Language interview/Manager interview/HR interview Employment: Employee of Mayflower Language Services Pvt Ltd (Datamundi.ai). Job description: Key Responsibilities: As a Business Architect, you will define opportunities to create tangible business value for the client by leading current state assessments, identifying high-level customer requirements, and developing business solutions and structures to achieve the vision. You will also develop a business case to realize these opportunities. Roles & Responsibilities: - Expected to be an SME. - Collaborate and manage the team to perform. - Responsible for team decisions. - Engage with multiple teams and contribute on key decisions. - Provide solutions to problems for their immediate team and across multiple teams. - Lead the development of business architecture and ensure its alignment with strategic objectives. - Define the principles, guidelines, and standards to ensure consistency across the organization. - Collaborate with stakeholders to understand their needs and align business architecture with their requirements. Professional & Technical Skills: - Must To Have Skills: Proficiency in Guidewire Digital Portals. - Strong understanding of business process modeling and business architecture frameworks - Experience in defining and implementing business strategies. - Ability to communicate complex ideas effectively to stakeholders. Good To Have Skills: Experience with business process management tools. Additional Information: -The candidate should have a minimum of 5-8 years of experience in Guidewire Development - This position is based at our Bangalore office - A 15 years full-time education is required Preferred candidate profile Guidewire Developer NOTE: If interested, please share us your updated resume and PAN card. If hesitant to share PAN, then Please ensure your resume name is as per your PAN card as it will be safe for BGV process if shortlisted for the position with Accenture .

Summary: The project manager role involves driving and managing project starting from planning, initiation to successful delivery of a project in accordance with objectives, milestones, quality standards, timelines and budgets throughout the project lifecycle in coordination with internal & external stakeholders Role & responsibilities 1. Lead and manage Cybersecurity projects from initiation to successful delivery of a project in accordance with objectives, milestones, quality standards, timelines and budgets throughout the project lifecycle, ensuring alignment with organizational security goals. 2. Collaborate with internal & external stakeholders including technical inputs from subject matter expert to collate the project requirements, scope, goals, deliverables, timelines, and budgets etc. 3. Develop detailed project plan/s with WBS to drive the project to meet program objective & stakeholders requirement. 4. Ensure appropriate resource allocation to meet program needs and minimize resource contention. 5. Ensure stakeholders meetings to ensure all parties understand the deliveries and milestones and the resources that are assigned. 6. Ensure projects are delivered on time, within scope, within budget to meet the objectives. 7. Conduct risk assessments, escalate issues/risks and implement mitigation strategies to ensure timely and successful project completion. 8. Conduct periodic review meetings, communicate & publish project status highlighting the progress, risks, challenges & delays etc. to stakeholders and higher management. 9. Develop and manage the stakeholder communications plans; coordinate and communicate with cross-functional teams to facilitate collaboration. 10. Create and maintain project documentation including all project artifacts, architecture diagrams, technical specifications, and configuration documents, SOPs and all required documents to transition & handover project to the operations team. 11. As part of Vendor Management, work closely with vendors thereby defining requirements/BOQ negotiations, including RFPs/RFIs, contractual negotiations, and monitoring vendor performance. follow-up and escalate wherever required to avoid delays. 12. Assist in project management strategy development, and the overall service orientation of the PMO. 13. Foster a collaborative and positive team environment, promoting effective communication and problem-solving across infrastructure projects. 14. Ensure Cybersecurity controls and compliance standards such as NIST, ISO 27001, GDPR are incorporated into projects. Knowledge: 1. Strong understanding of Cybersecurity concepts, standards, frameworks and compliance requirements (eg. NIST, CIS controls, ISO 27001). 2. Project/program management experience with proficiency in project management methodologies and tools. 3. Experience in coordinating cross-functional teams and managing projects with a focus on quality and efficiency to successfully deliver the projects 4. Strong project management skills, including the ability to develop and maintain project plans, monitor progress, and manage budgets and resources. 5. Knowledge of regulatory requirements such as GDPR, PCI-DSS. 6. Knowledge of IT infrastructure (networs, servers, cloud environment etc.) to effectively engage with technical teams. 7. Proficiency in Project Management tools as well as managing projects without tool. Preferred candidate profile 1. Exceptional analytical, conceptual thinking and problem-solving skills. 2. Excellent communication and interpersonal skills, with the ability to understand complex business requirements and translate them into project management requirements. 3. Detail-oriented with a focus on quality and accuracy in project/service deliverables 4. Should have strong written, verbal and presentation skills. 5. Ability to perform under pressure, influence stakeholders and work closely with them to determine acceptable solutions. 6. Strong negotiation, and conflict resolution skills.

We are seeking an experienced and strategic leader to head our Commercial & Logistics operations. This role will be responsible for overseeing all international trade activities, ensuring compliance with regulations, benefit management, optimizing cost and efficiency of export and import operations and enabling smooth cross-border movement of goods. The ideal candidate will bring deep domain knowledge, leadership capabilities, and a proven track record in managing large-scale import/export functions preferably from pharmaceutical industry. Reporting Structure: Global Supply Chain Head Experience Any Bachelors degree, EXIM Management, Supply Chain Management, or related field. MBA preferred. 15-18 years of relevant experience, with at least 5 years in a leadership role Should have led the EXIM function with a team of 5 to 6. In-depth knowledge of Indian customs regulations, INCOTERMS, export-import documentation, and compliance procedures including EDPMS/IDPMS. Strong experience in working with DGFT, Customs, ADC, SEZ, EOU, and related government authorities including trade bodies like CII, FIEO, EPCs etc. Experience in handling GDP, AEO, Compliance Tool, Benefit Management (RoDTEP, Duty Drawback, Deemed Export Drawback, TED). Excellent leadership, negotiation, and communication skills. Should be in SME role in the current organization to advise stakeholders on various international topics like : budget impact, trade barriers, duty structure. Key Roles and Responsibilities Strategic Leadership: Develop and implement the overall strategy for export and import operations in alignment with global business goals. Identify and drive opportunities for operational improvements, cost optimization, and trade expansion. Collaborate with cross-functional teams including procurement, manufacturing, BD / Sales, warehouse, finance and legal. Compliance & Risk Management: Ensure full compliance with Indian customs regulations, international trade laws, EXIM policies, Drugs & Cosmetics Act, FSSAI and other relevant statutory bodies. Monitor changes in trade laws and implement internal changes to stay compliant. Manage risk through effective documentation, due diligence, and contract management. Operations Management: Oversee end-to-end import/export documentation, logistics coordination, HS classification, duty payments, and clearance processes. Manage relationships with customs brokers, freight forwarders, shipping lines, CHAs, and port authorities. Ensure timely and cost-efficient international shipments, with optimal inventory levels and minimal delays. Team & Vendor Management: Lead and mentor the export-import operations team. Logistics partners management to ensure cost-effective and reliable shipping solutions. Develop KPIs to monitor vendor performance, customs cycle times, and shipment accuracy. Financial Control: Monitor and manage budget for international logistics. Track and report import duties, shipping costs, and ensure proper documentation for tax and audit purposes. Optimize use of duty drawback schemes, EPCG licenses, Advance Authorization schemes, etc. Competencies Strategic Thinking & Execution Attention to Detail & Regulatory Knowledge Liaison, Negotiation & Relationship Management Good in written and verbal communication for trade related representations Operational Excellence Team Leadership & People Development

The Junior Executive – Warehouse will support day-to-day operations within the warehouse to ensure the proper handling, storage, and dispatch of pharmaceutical products in compliance with regulatory and company standards. The role involves inventory

QC Manager/ Sr. Manager Job Responsibilities Training to staff for following practices as per standard operating procedure, Good Laboratory Practices and Pharmacopoeia / in-house method of analysis To monitor data integrity in Compliance of good laboratory practice and Compliance of GMP in the Quality Control Laboratory. To check and sign Certificate of Analysis (COA) for export as well as domestic. To review and ensure Deviation, Corrective action Preventive action (CAPA) report, Market Complain Investigation related activity and its implementation. To review risk assessment and appropriate measures to mitigate the risk and to prevent reoccurrence of risk. Ensuring effectiveness and applicability of the QA system through self-inspection and Quality audit. Improvements / revision in Standard operating procedures as per procedure and their implementation from time to time. To monitor retain samples/logs and physical observation as per standard operating procedure. To monitor stability samples, test frequency and summary results. Monitoring of necessary testing being carried out timely as per specifications and method of analysis and release of certificate of analysis. To monitor maintenance/ repairing of instruments and their annual maintenance contract from external agencies. Co-ordination with public testing labs for timely test report. Getting technical agreement with them, pay visit at time of test to monitor correct method of analysis, whenever necessary. Interdepartmental co-ordination for smooth working to reduce down time in mfg. & packing of various products. To manage for incidents for all testing related chemicals/ apparatus/ standards/ media/ accessory/ parts/ books/ stationary/ dress/ men power requirement, new machine requirement. etc, for timely testing for API/ excipients/ In-process/ finished products/ stability samples etc. Supervision, guidance and inspiration to down the line colleagues for improvement of systems with respect to quality/ data integrity/ efficiency/ correct work procedure etc. To investigate Out of Specification/Out of trend and take appropriate corrective action and preventive action as per standard operating procedure. To prepare risk analysis documents and monitor for probable risks in testing/ reporting, train staff accordingly. Active participation in technology transfer and validation exercise. Evaluation and monitoring of trend data. Monitoring soft data management. To Review and Approved Finish Product (Injection/API), Raw material, Packing material Specification, Standard Operating Procedure, Analytical Work record. To release and approved Raw material / Packing Material in SAP system along with Certificate of analysis (COA). To approved Certificate of analysis (COA) and Release the Semi-finished & Finish product in SAP system. (i.e. I1 and A1) To conduct internal audit / External Audit / self-inspection to ensure compliance to GMP and other regulatory

Job title ADL executive Division phrama Function Analytical method validation Location dombivali Designation ADL executive Job Grade Reporting to (position) ADL Head Direct Reportees (Nos) Company Name Aart industries limited Key Role & Responsibilities 1)Able to performed method validation on GC HS 2)analytical method transfer 3) Able to performed method validation on GCMS 4)method development on GC 5)Handling incident and deviation 6) online review of system,log books 7)Aware of 21 CFR part 11 guidlines ICH and Anvisa Guidlines 8) GC MS and LCMS Linkages within / outside the organisation Internal External Job specification Experience min 9 years Qualification MSc CTC Range as per company based on skill and knowlage Target Company if Any Certifications/Trainings Skills / Competencies Have good knowledge of GC gcms Awareness 21 CFR part 11 knowledge of GMP and GDP handled OOS,OOT incident deviation able to work in shifts. analytical method validation FDS study and photostability Role & responsibilities Preferred candidate profile Perks and benefits

Role & responsibilities 1) To perform the analysis by following cGMP, GLP, ALCO+, and safety compliance 2) To perform the sampling, testing of RM, PM, In-process, Intermediate and Finished product. 3) Participate in Investigation of deviation, Incident, OOS etc. 4) To perform all qualification activities of instrument and equipment in QC Lab. 5) Aware of calibration and operation procedure for instruments ( balance, K.F, GC. UV,refratometer and viscometer etc,) 6) Experience of QC software like Tiamo 3.0, Lab solution, SCM etc. 7) Preparation of documents ( SOP, protocol etc) related to Quality control.