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2.0 - 7.0 years
4 - 7 Lacs
ahmedabad
Work from Office
protocol & reports of equipment / utility qualification Responsible for execution of equipment / utility qualification. process validation cleaning validation Annual Product review Validation Master Plan. Computer System Validation/ PLC validation Perks and benefits Food & Transportation, Bonus & Gratuity Separately
Posted 1 day ago
7.0 - 12.0 years
7 - 11 Lacs
dombivli
Work from Office
(QMS) implementation, Manage Change Control, Deviations, and CAPA to maintain product quality. Conduct Vendor Qualification & audits. Ensure GMP practice. Stability Studies & ensure compliance with ICH guidelines. Time Studies & process optimization.
Posted 1 day ago
0.0 years
0 Lacs
hyderabad, telangana, india
On-site
Job Responsibilities To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies. To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness. To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date Approved Vendor List and requalification of Vendor Schedule. To ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation. Responsible for ensuring QMS elements (Change Control, Deviations, CAPA, OOS, OOT, etc.) are implem...
Posted 1 day ago
5.0 - 8.0 years
3 - 6 Lacs
kalol, mehsana, ahmedabad
Work from Office
Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...
Posted 2 days ago
8.0 - 12.0 years
0 Lacs
karnataka
On-site
Role Overview: As a Costing & Sourcing Specialist at Syngene, you will be responsible for managing procurement, RFX, and costing of Biologics raw material, consumables, and Media/Resin on a commercial scale. Your core purpose will include developing procurement category management strategies for the Biologics operating unit in compliance with Current Good Manufacturing Practices (cGMP). You will also be expected to drive supplier life cycle management, negotiations, supplier consolidation, and strategic relationship management to optimize supplier performance and achieve cost savings. Key Responsibilities: - Develop and execute procurement category management strategies for Biologics operati...
Posted 3 days ago
5.0 - 9.0 years
0 Lacs
pune, maharashtra
On-site
As a Quality Engineering Specialist within the Medline UNITE Foot and Ankle Orthopaedics Division in Pune, India, you will play a crucial role in maintaining quality standards aligned with strategic engineering objectives. Your responsibilities include providing quality support for complaint investigations, routine product evaluations, product testing, documentation, and vendor qualification processes. Additionally, you will contribute to new product development and legacy engineering projects related to implantable foot and ankle products and accessories. Your ability to thrive in a team environment, demonstrate a strong sense of urgency, and build effective working relationships with peers...
Posted 6 days ago
10.0 - 15.0 years
9 - 19 Lacs
gummidipoondi, chennai, thiruvallur
Work from Office
Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...
Posted 6 days ago
1.0 - 5.0 years
3 - 6 Lacs
bangalore rural
Work from Office
Responsibilities: * Ensure quality control through inspections * Conduct vendor assessments & develop strategies * Manage expediting process from order to delivery * Oversee vendor qualifications & registrations
Posted 1 week ago
2.0 - 7.0 years
2 - 5 Lacs
tarapur, boisar, palghar
Work from Office
Key Responsibilities: Overall looking for documentation work of Engineering Department and presenting as Engineering Q.A. Active Participation with Q.A in Audit Works. Active participation in QMS work i.e QAP and relevant documents for EU Audits. Scheduling, Planning, Executing Departmental working & documentation work for Engineering Drafting of QAP, SOP, Logbooks, Documents, etc and timely revision according to schedule. Drafting of Engineering SOPs for all machines/utilities accordance with manufacturer recommendations along with performing Qualification activities and accordingly designing logbooks and records. Drafting of In-house Qualification documents with respect to manufacturers do...
Posted 1 week ago
8.0 - 9.0 years
0 - 0 Lacs
noida
Work from Office
Role & responsibilities: Preparation and review of SOP. Preparation and monitoring of change control, deviation control. Review and approve the Standard Operation Procedure, Product Quality Reporting System (PQRS), Change control, Deviation controls/Analytical Protocols/Stability protocols/Qualification and validation protocols and reports. In-Process checking during online activities. To ensure timely submission of audit compliances for the deficiency during the inspections/audits Monitoring of GMP compliance. Review of quality documents and analytical data as per pharmacopeia specification, STP, batch card, stability finish product, packaging materials for the purpose of compilation of dos...
Posted 1 week ago
8.0 - 13.0 years
7 - 9 Lacs
boisar, palghar, mumbai (all areas)
Work from Office
Role & responsibilities Vendor Assessment & Qualification. Documentation & Record Management Vendor Approval & Monitoring Compliance & Regulatory Support Vendor Validation Preferred candidate profile Minimum 8 years of experience in Vendor validation role. Knowledge of GMP, GLP, ISO, and regulatory guidelines Strong documentation, communication, and analytical skills.
Posted 2 weeks ago
5.0 - 8.0 years
7 - 10 Lacs
hyderabad
Work from Office
Role & responsibilities * Prepare and Review SOPs and Guideline for DQA. * Formulate Documentation Process for the Key divisions of SRD and ARD. * Review documents with respect to drug substance such as protocols, SOPs, test methods, data COAs and report through collaborate with CRD, ARD, and QC scientists. * Successfully manage and complete all Audits that come up from time to time and conduct periodic internal audits and ensure compliance as per regulatory requirements * Review process development documents including KSM/KRM identification, specification proposal, analytical method development and validation reports, stability protocols& reports and safety studies. * Handle Vendor Qualific...
Posted 2 weeks ago
0.0 years
2 - 4 Lacs
mangaluru
Work from Office
Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
As an Instrumentation Engineer, your role will involve the following tasks: - Preparation of P&ID from PFD, Instrument Index & I/O list, and Instrument specification datasheets. - Identifying vendors and qualifying them based on the client's requirements and vendor performance. - Interacting with vendors to define requirements and obtain quotes. - Establishing methods and systems for maintaining the quality of procured instruments. - Conducting pre-delivery inspections and FAT in accordance with required standards. - Performing technical and commercial bid comparisons and costing of instrumentation in projects. - Proficient in finalizing control philosophy using SCADA or PLC systems. - Handl...
Posted 2 weeks ago
5.0 - 8.0 years
10 - 14 Lacs
bengaluru
Work from Office
Senior Manager 1
Posted 2 weeks ago
6.0 - 11.0 years
4 - 9 Lacs
boisar, palghar
Work from Office
Overall looking for documentation work of Engineering Department and presenting as Engineering Q.A. Active Participation with Q.A in Audit Works. Active participation in QMS work i.e QAP and relevant documents for EU Audits. Scheduling, Planning, Executing Departmental working & documentation work for Engineering Drafting of QAP, SOP, Logbooks, Documents, etc and timely revision according to schedule. Drafting of Engineering SOPs for all machines/utilities accordance with manufacturer recommendations along with performing Qualification activities and accordingly designing logbooks and records. Drafting of In-house Qualification documents with respect to manufacturers documents. Co-ordination...
Posted 3 weeks ago
8.0 - 10.0 years
8 - 12 Lacs
bengaluru
Work from Office
Further to the discussion, please refer the JD below and revert. BE Mechanical/Electrical with 8+ years of experience, having expertise in MEP-Contracts, Fire protection systems, and other MEP services for Hospitality Projects(High Luxury Hotels). Knowing the basics of contract terms & conditions & current market rates. Experience in handling all packages of MEP for a Greenfield project-preferably Hotels but not mandatory. Core Responsibility: 1. Knowledge of MEP related services such as Electrical, PHE, FF, HVAC, STP, WTP, Security and Surveillance, Networking etc., 2. Knowledge of MEP sequence of works, IS codes, rate analysis of items etc. 3. Pre-qualification and short-listing of contrac...
Posted 3 weeks ago
1.0 - 5.0 years
3 - 5 Lacs
hosur
Work from Office
Role & responsibilities 1. Knowledge of ISO 9001, 14001, FSSC 22000, HACCP and cGMP standards requirement. 2. Supporting Regulatory, Certification and Customer Audits to QA 3. Implementing of related SOPs and OCP of the department. 4. Follow up and collecting Vendor Qualification questionnaires, Declarations, Nitrosamine questionnaire, Technical/Supplier Agreement, Assessment Report, Certificates and ISO audit related documents from vendors. 5. Preparing Approved Vendor list and Vendor rating Preferred candidate profile Female
Posted 3 weeks ago
3.0 - 7.0 years
0 Lacs
noida, uttar pradesh
On-site
As a Purchase Engineer in the Procurement / Supply Chain department of an EPC (Engineering, Procurement & Construction) company located in Noida, your primary role will involve procurement planning and execution. This includes understanding project BOQ and technical specifications to source materials, equipment, and services, coordinating with engineering and project teams for procurement needs, and creating RFQs for vendors and subcontractors. Key Responsibilities: - Understand project BOQ and technical specifications for sourcing materials, equipment, and services - Coordinate with engineering and project teams for procurement needs and schedules - Create and issue RFQs to vendors and subc...
Posted 3 weeks ago
5.0 - 9.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Parts Operation Quality Manager at Siemens Energy, you will play a crucial role in handling quality control functions for the Spare Parts Operations at the manufacturing facility in Naroda. Your responsibilities will include: - Independently managing and optimizing quality control function related to spare parts operations. - Overseeing supplier quality and inspection of parts. - Aligning customer quality requirements with SE standards. - Collaborating with the team to achieve and enhance KPIs like OTD, customer satisfaction, NCCs, and ensuring the first-time right product delivery. - Conducting vendor qualification/audits as needed. - Inspecting parts quality by visiting vendors or thr...
Posted 3 weeks ago
10.0 - 14.0 years
0 Lacs
jharkhand
On-site
Job Description: As the Manager Supplier Compliance, you will be responsible for various vendor compliance activities. Your role will involve daily management and preparation of the vendor qualification and requalification program, overseeing the annual global supplier bona fide program, managing the global distributor chain of custody verification program, and administering the Quality Agreement program for Suppliers within your team's responsibilities. Additionally, you will maintain Global GMP Vendor Master/Qualification Data in SAP, handle expiration dating, ensure timely escalation and remediation of supplier compliance risks and failures, and exhibit Endo Values and commitment to the E...
Posted 3 weeks ago
8.0 - 10.0 years
8 - 10 Lacs
patancheru, hyderabad
Work from Office
Ensure/Verify—batch release, SOP compliance, GMP & documentation control Record & review—all production and Engineering & Maintenance activity & related QMS Conduct—Audits, gap analysis. Prepare—DMF, CTD, VMP, SMF, protocols Required Candidate profile QA lead—oral solids SOP/GMP & doc control QMS—deviations/CAPA/CC/complaints, root cause investigation APQR process/cleaning validation & CSV IQ/OQ/PQ & calibs stability & summaries auditing DMF/CTD
Posted 3 weeks ago
6.0 - 10.0 years
7 - 12 Lacs
hosur
Work from Office
Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per d...
Posted 3 weeks ago
5.0 - 9.0 years
0 Lacs
karnataka
On-site
As a Battery Pack Design Engineer with the battery pack engineering team in Bangalore, you will be working on multifaceted structural, electrical, and thermal problems. Your main responsibilities will include designing and developing components and assemblies for production, testing, POC, and driving safety aspects of highly integrated batteries. Your influence on product direction will be significant as you lead the design and execution of battery testing to explore novel materials and new design concepts, ensuring that Pravaig becomes a leader in battery technology. **Responsibilities:** - Experience in structural, electrical, thermal, and mechanical battery systems. - Strong analytical an...
Posted 3 weeks ago
3.0 - 7.0 years
0 Lacs
ankleshwar, gujarat
On-site
Role Overview: As a Senior QC Officer reporting to the Head QC, you will be responsible for performing various Quality Control activities in the pharmaceutical industry. Your role will involve ensuring that all QC activities are conducted according to defined Standard Operating Procedures (SOP) and documented promptly. You will have a crucial role in analyzing raw materials, in-process materials, equipment cleaning verification, vendor qualification, and finished product samples accurately and on time. Additionally, you will be required to calibrate QC instruments daily, prepare and maintain standard solutions, and generate certificates of analysis post-analysis. Your contribution will also ...
Posted 3 weeks ago
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