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3.0 - 7.0 years

0 Lacs

karnataka

On-site

As an Analytical Chemist at our company, you will be responsible for developing analytical methods using techniques such as HPLC, GC, LCMS, KF, and FTIR for routine analysis. You will also be in charge of maintaining analytical documentation including protocols, specifications, etc. Calibration of HPLC and GC instruments will be part of your regular tasks. It is essential that you are knowledgeable about data integrity and ALCOA guidelines. Additionally, you will be involved in chiral method development to support our analytical processes.,

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0.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Analytical method development Routine Analysis by HPLC, GC, LCMS, KF and FTIR Analytical documentation as like Protocols, specifications etc. Calibration of HPLC, GC instruments Aware about data integrity and ALCOA Chiral method development Show more Show less

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3.0 - 7.0 years

0 Lacs

karnataka

On-site

Job Description: As an Executive or Senior Executive at Syngene, you will be responsible for method development, validation, and stability testing of drug substance/drug product. Your primary role will involve having strong hands-on experience in developing and validating Assay & related substances methods for drug substance/drug product. Additionally, you will be expected to work with complex injectables and be willing to work in shifts. Your core responsibilities will include handling instruments such as HPLC, UPLC, GC, UV Visible spectrophotometer, balances, Potentiometer, and stability chambers. You must be well-versed in Good documentation/laboratory practices like ALCOA+ and have experience in calibration and qualification of laboratory instruments. Furthermore, you will be accountable for preparing and reviewing raw data sheets, instrument operating procedures, and standard operating procedures. In this role, you will also be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares required for projects. Adherence to GxP/Safety procedures and internal standard operation procedures is crucial. Proficiency in operating MS Office tools and effective communication skills are essential for interactions with clients and external users. To excel in this position, you should possess good interpersonal skills, self-time management abilities, and be a strong team player. The role also requires polite and effective communication skills. Syngene Values: At Syngene, we uphold the values of Excellence, Integrity, and Professionalism, and as a team member, you are expected to consistently demonstrate alignment with these core values. Specific Requirements: - Experience: 3-6 years - Skills And Capabilities: Hands-on experience in HPLC, UPLC/UHPLC, GC, UV-Visible spectrophotometer, Potentiometer, and other analytical instruments. Knowledge of good documentation/laboratory practices such as ALCOA+ is required. Experience in particle size determination, Zeta potential, and particulate matter analysis techniques will be advantageous. Familiarity with SEC, CGE methods for mAbs is a plus. Proficiency in MS Office tools is necessary. - Education: M. Pharm /M. Sc with 3-6 years" experience in R&D under GMP environment (QC) If you meet the requirements mentioned above and are looking to contribute to a culture of safety, innovation, and excellence, we invite you to apply for this exciting opportunity at Syngene.,

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3.0 - 7.0 years

0 Lacs

indore, madhya pradesh

On-site

We are looking for a Computer System Validation (CSV) Engineer with specialization in SAP HANA/S/4HANA validation to join a prestigious MNC Pharma company at their corporate headquarters in Mumbai. As a CSV Engineer, your main responsibilities will include developing and overseeing CSV deliverables such as VP, URS, FRA, IQ/OQ/PQ, etc. It is essential to ensure adherence to regulatory standards like 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborating with diverse teams including QA, IT, and BPOs will be a key aspect of your role. Additionally, managing SAP system upgrades, patches, and audits will be part of your day-to-day tasks. The ideal candidate should hold a Bachelor's degree in Computer Science, Engineering, or Life Sciences and possess a minimum of 3 years of experience in CSV within regulated industries. Proficiency in GxP, ALCOA+, and data integrity standards is required. Candidates with SAP HANA Certification and experience in audit trails, security roles, EDMS/QMS are preferred for this role. This is a full-time position located in Mumbai. To apply, please send your CV to ankur.tiwari@ics-india.co.in or contact +91 9109188512. Join us now and contribute to the global pharmaceutical innovation journey.,

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4.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

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4.0 - 6.0 years

2 - 7 Lacs

Hyderabad

Work from Office

Role & responsibilities: Issue of Study Documents, SOPs, Work Instructions, Method Procedures, Test Procedures, Forms, Manuals & Logbooks. Archival and Retrieval of study documents & General Documents. Maintenance of Sops work instructions, Forms, Manuals, Bincards, Logbooks and general documents indexes. Maintenance of studies archival list with third party (WIMS). Obsoletion of Sops, work instructions, Forms & general data scanned & Ture copy certification. X-Ray evaluations year wise verified. Screening failures & Validity completed documents are arranged & scanned, verified true copy certification. Agreements, vendors, consultants due dates verification and maintenance of indexes. All department Sops review dates also maintained ii year wise. Maintenance of all employee training records with hard copy and scan copies. Maintenance of study documents, general documents and sent to archival for third party WIMS. Updating indexes of archival racks for identifying study and general documents. Maintenance of all left employee training records with hard copy and scan copies verified and done by true copy certification. Maintenance and archival of Calibrations, Qualification and Method Validations general files along with updated index labels. All other activities assigned by department head as per requirements. Preferred candidate profile: Interested and suitable applicants can mail their updated CV to hr@qpsbioserve.com. Note: We are looking for candidate who are willing to join on immediately.

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2.0 - 6.0 years

2 - 7 Lacs

Hyderabad

Work from Office

Hiring: Operators & Officers for OSD Production & Packing (Onco & Non-Onco) | Sterile Production | Quality Control | Microbiology Interview Location: Elite Hotel, Jadcherla Walk-in / Immediate Joiners Preferred 1. Operators & Officers for OSD Production & Packing (Onco & Non-Onco) Experience: 2 to 6 Years Qualifications: I.T.I / Diploma / D. Pharmacy / B. Pharmacy Job Responsibilities: Operation of equipment: Granulation, Compression, Coating, Capsule Filling, Blister & Bottle Packing Supervision of Granulation, Compression, Coating, and Packing lines (Blister/Bottle) 2. Officers & Operators for Sterile Production (Onco) Experience: 2 to 6 Years Qualifications: Diploma / B. Sc / D. Pharmacy / B. Pharmacy Job Responsibilities: Supervision of Manufacturing, Compounding, Filling, Filtration, and Packing areas Strong knowledge of QMS (minimum 5 years preferred) Hands-on experience in Manufacturing and Compounding Operation of equipment in Filling, Filtration, and Packing 3. Analyst for Quality Control Experience: 2 to 5 Years Qualifications: M.Sc / B. Pharmacy Job Responsibilities: Analytical testing of Finished Products, Stability Samples, and Packaging Materials Proficient in handling instruments HPLC, LIMS, Dissolution Apparatus, UV Spectrometer, KF Apparatus, IR Spectrometer, Metrohm Auto Titrator RM/PM/IP/FP analysis, Assay, and Dissolution using HPLC Strong understanding of GLP, GDP, cGMP, ALCOA & ALCOA+ principles 4. Microbiologist for QC Micro (OSD / Injectables) Experience: 0 to 6 Years Qualification: M. Sc (Microbiology) Job Responsibilities: MLT & BET Analysis, Sterility Testing Water Sampling and Analysis Environmental Monitoring Activities Note: Only Formulation experience with Regulatory exposure will be considered.

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2 - 7 years

2 - 7 Lacs

Ahmedabad, Rajoda, SEZ Matoda,Rajoda

Work from Office

Walk-in Drive @ Ahmedabad on 18th May'25 (Sunday) for Quality Control Department We are looking for suitable candidates for OSD Quality Control for Ahmedabad location Unit Interview Venue Details: Date: 18th May 25 (Sunday), Time: - 9:00 AM to 1:00 PM Venue : Amneal Pharmaceuticals Pvt. Ltd Survey No. 634,637-641 Village: Rajoda Tal: Bavla Dist: Ahmedabad -Gujarat - 382220 1) REQUIREMENT FOR OSD QUALITY CONTROL DEPARTMENT Total Experience: 02 to 7 years (Pharma experience only) Qualification: B.Sc./ M.Sc/ B. Pharm/ M. Pharm Designation: Officer/ Sr. Officer /Executive/ Sr. Executive Department: Quality Control Desired Profile: Test RM, PM, in-process, finished & stability samples (various dosage forms i.e., tablet, Capsules, oral suspension/ ointment/powder etc) as per SOPs/pharmacopeia Operation of HPLC, GC, UV, FTIR, Dissolution, KF, wet & physical tests Troubleshoot basic issues Ensure ALCOA adherence in shift activities Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP and understanding of regulatory requirement will be preferred. Note : Candidate should relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliant) organization. Kindly carry your updated CV along with copies of CTC proof, Appointment letter, Increment letter, last 3 months salary slips, Bank statement, Education certificates & Marksheets, Aadhar & PAN card and passport size photograph, at the interview venue. Disclaimer: Beware of fake job offers claiming to be from Amneal Pharmaceuticals Pvt. Ltd. or Companies under Amneal Group (collectively referred to as AMNEAL). Amneal neither send job offers from free email services like Gmail, Rediffmail, Yahoo mail, Hotmail, etc. nor charges any fees/security deposit from any job seekers. Amneal will not be responsible to anyone acting on an employment offer not directly made by Amneal. Stay vigilant and report any suspicious activity to Amneal.

Posted 2 months ago

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