532 Cgmp Jobs - Page 18

24 7 audit readiness Exposure in Wet Chemistry & responsible to works in different shifts Perform the raw material analysis & wet lab activity by using the technique (KF, pH, KFC, UV, FTIR, SOR, Oven, Auto titrator, Polari meter & TLC) etc. Sampling of Raw material / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms Perform analytical test according to the monograph and SOP & follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory Participation in internal, external, regulatory audits & Ensure 100% participation in training s against CAPA s Responsible for initia...

Carrying out dispensing activities as per applicable procedure. Carrying out process and sampling activities during the production of Intermediate /API s according to approved batch cards. Responsible for recording the observations of reaction parameters on the batch card as per approved procedure. Filling of all the batch cards (production cleaning) as per approved instructions. Ensure verification of pH meters and weigh balances as per applicable procedures. Maintain work procedure, safety precaution and cGMP. Ensure housekeeping of plant and cleanliness of the equipments , update the equipment Report accidents and irregularities at the work station to the Shift Officer. Extensive equipmen...

Roles and Responsibilities: Production Scheduling, Coordination with Departments, Capacity Planning, Risk Assessment, Inventory Control, Lead Time Management, Adherence to Standards, Documentation, Collaboration with Sales team, Cost Control.

Role & responsibilities : Assist in the preparation, review, and submission of regulatory documents Help maintain regulatory files and records Support in compiling dossiers for product registrations and renewals Research regulatory requirements and updates from national/international authorities Coordinate with cross-functional teams for required data or documents Share your resume to hrd@stedmanpharma.com / 9786920463 Preferred candidate profile : This internship is ideal for students or recent graduates looking to gain hands-on experience in the field of Regulatory Affairs within the pharmaceutical industry. The intern will work closely with the RA team and assist with documentation, compl...

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Location - Mysore Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental pro...

Maintain QMS & ensure compliance with GMP standards across the plant Conduct audits, compile reports, approve vendors for RM & packaging Review documentation like SOP, BMR, BPR, APQR, etc Handle deviations, complaints, OOS reviews, and implement CAPA Required Candidate profile Experience facing audits in the pharma intermediates/API/bulk drug industry only; formulation experience not relevant Excellent communication skills for audits. Fluency in English & MS Office.

Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned depa...

Position- Manager - Sourcing (Pharma) Key Responsibilities: Sourcing & Procurement: Lead the procurement of Raw Materials, excipients and APIs from China, India and Europe, ensuring availability and regulatory compliance. Develop and implement strategic sourcing plans to optimize costs, quality, and supplier performance. Supplier Relationship Management: Establish strong relationships with suppliers, ensuring timely deliveries and addressing supply disruptions. Conduct supplier audits and manage quality agreements. Mangement of confidential, commercial, exclusivity and representation agreements. Regulatory Compliance: Ensure sourcing practices align with cGMP, ICH, and relevant FDA/EMA guide...

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

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • You will be responsible for coordinating with cross functional teams for ensuring that preventive maintenance is carried out as per schedules in SAP. • Your role involves preparing the PMP (Preventive Maintenance Plan) and maint...

JOB DESCRIPTION Job Title: Costing & Sourcing Specialist Job Location: Bengaluru About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself ...

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit ...

Role Summary: We are seeking a highly competent and detail-oriented Manufacturing QA Personnel with substantial experience in Sterile Injectable manufacturing , specifically focusing on Small Volume Parenterals (SVP) including Dry Powder, Liquid, and Lyophilized Injections . The selected candidate will ensure shop floor compliance and enforce GMP practices to maintain a state of readiness for inspections and regulatory compliance. Role & responsibilities : Ensure cGMP compliance on the shop floor during all stages of sterile manufacturing (formulation, filtration, filling, lyophilization, sealing, and visual inspection). Conduct and supervise line clearance, in-process checks, and aseptic pr...

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 01 Quality Control Functions: 1.1 To ensure that the laboratory carrying out its testing, calibration, validation and all other technical activities in such a way to meet GLP requirements. 1.2 To carry out all technical activities and implementation of documented quality system. 1.3 To plan, schedule and monitor analysis of Raw Materials, Premix, Packing Materials, In-process materials, Finished products, Microbiological analysis, Water analysis and ensure that they meet defined relevant quality standards. 1.4 Periodically review logbooks, reports and test protocols related to Raw Materials, Premix, Packing Materials, Microbiological analysis, In-process and Finished ...

QA Specialist What you will do In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organisations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of contract manufacturers. Perform tactical batch disposition activities in support of lot release Enter and approve analytical data in LIMS Manage and drive Quality records ...

Position Overview: We are looking for a Sr. Manager will be responsible for leading and managing end-to-end multiple API production blocks. The role requires ensuring optimal productivity, quality, cost control and regulatory compliance in alignment with cGMP standards. This position plays a critical role in driving continuous improvement, cross-functional coordination, and operational excellence within the production unit.. Key Responsibilities: Oversee daily production activities to ensure efficiency, quality, and cost-effective management of resources. Develop and implement production schedules based on inventory / market requirements / capacity constraints and provide feedback accordingl...

Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible to follow all regulatory/cGMP/Statutory/Company policies are followed in manufacturing area. Responsible for online documentation with real time data. Responsible to participate in equipment qualification and process validation activities Preferred skills : Granulation, Compression, coating and packing of & Exposure in OSDs

Review SOP Support quality system Familiar with process/cleaning validation Assist internal & external audits Assist specification settings, OOS investigation, change controls, regulatory submission/update, annual product reviews, other investigation Required Candidate profile Must have min. 2 yrs experience & must be familiar with cGMP requirements. Candidate should have good knowledge of computer & ability to effectively interact with individuals at all levels.

Preferred candidate profile Qualification : B Pharma/M Pharma Year of Experience : 5 - 6 Yrs in shop floor management. Must have hands on experience in Granulation Section. Having exposure of Audit facing internal and external party. Interested candidates may share profile at hr.plant@zuventus.com Job Location : Sikkim

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; ....

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 - 8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please S...

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Job summary We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines. Roles & Responsibilities • Your responsibilities encompass testing assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment w...

Walk-In Drive Hyderabad | June 1, 2025 Join our growing team at OneSource The new way to CDMO We're hiring for multiple roles across our R&D and Manufacturing facilities in Bengaluru. Walk-In Interview Details: Date: Sunday, June 1, 2025 Time: 9:00 AM 4:00 PM Venue: Oakwood Residence, 115/1, Road No. 2, Financial District, Gachibowli, Hyderabad, Telangana 500032 Open Positions: Process Development Lab (Unit 1, Bommasandra) Research Associate | Sr. Research Associate | Scientist Qualification: B.Tech / M.Tech (Biotechnology) Experience: 2 – 12 years Drug Substance Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive Qualification: MSc / B.Tech / M.Tech (Biotech, Microbiology) Expe...