237 Gdp Jobs - Page 9

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other re...

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise. Experience working in a GMP environment, 7+ years in an IT Systems Role. Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management. SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP) Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements. Comprehensive understanding of Quality Management processes, regulatory compl...

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 ...

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/repacki...

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 docum...

*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 Prot...

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, Suppl...

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 qua...

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 c...

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 Sit...

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 in...

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 ...

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 repea...

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 ...

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 ma...

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. ...

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

quality checks on raw materials, in-process, and finished product proper documentation as per GMP standard stability studies, sampling, and lab testing compliance with SOPs, regulatory, and safety guideline audits and assist in CAPA implementation