18 Alcoa Jobs

Job Title: Senior Trainer Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The ideal candidate should have in-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles , and be capable of delivering engaging, practical training to QA, QC, Manufacturing, and IT professionals. Key Responsibilities: Develop, design, and deliver training programs on Computerized System Validation (CSV) and Data Integrity (A...

This is where your work makes a difference. At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. He...

You will be responsible for conducting WET, GC, and HPLC analysis as an Expert in the field. Your role will involve ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and ALCOA+ guidelines. Key Responsibilities: - Conduct WET, GC, and HPLC analysis - Ensure compliance with GMP, GLP, GDP, and ALCOA+ guidelines Qualification Required: - M.Sc. in Chemistry - 3 to 5 years of experience - Good knowledge of GMP, GLP, GDP, ALCOA+ - Expertise in WET, GC, HPLC Analysis,

Job Type : Long-Term Contract About The Role We are looking for an experienced CSV Lead with deep expertise in Computer System Validation, SAP S/4HANA upgrades, and strong Japanese language proficiency (JLTP N1). This is a remote, long-term contractual role ideal for a proactive professional who can manage validation activities and compliance processes independently while collaborating in a global, cross-functional environment. Key Responsibilities Lead and manage CSV (Computer System Validation) activities across the project lifecycle, including concept, implementation, operations, and retirement phases. Work closely with teams involved in SAP S/4HANA upgrade initiatives. Review and approve...

You will be responsible for Vial washing, Depyrogenation tunnel, and filling with isolator activity for startup and routine operation. Ensure to adhere to cGMP and ALCOA in your daily tasks and follow organization policies and procedures. Your duties will include preparation and implementation of procedures related to qualification and maintenance activities for the Injectable facility. Review, implement, and maintain cGMP standards in all work areas. You will also be involved in preparing, reviewing, approving, and implementing Standard Operating Procedures and following guidelines. Your goal will be to meet the monthly productivity targets and ensure dispatches are made as per the schedule...

Role Overview: As a Computer System Validation (CSV) Engineer specializing in SAP HANA/S/4HANA validation at a prestigious MNC Pharma company in Mumbai, your primary responsibility will be to develop and oversee CSV deliverables, including VP, URS, FRA, IQ/OQ/PQ, etc. It is crucial to ensure compliance with regulatory standards such as 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaboration with various teams such as QA, IT, and BPOs will be a vital aspect of your role. Additionally, you will be involved in managing SAP system upgrades, patches, and audits as part of your daily tasks. Key Responsibilities: - Develop and oversee CSV deliverables like VP, URS, FRA, IQ/OQ/PQ, etc. - Ensure compl...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

As a Product Owner for ELN platforms such as Benchling, iLab, and Biovia, you will be responsible for defining and managing the product vision, roadmap, and backlog for ELN solutions in the Pharma or Life Sciences industry. Your role will involve gathering and prioritizing requirements from R&D, lab users, and business stakeholders to ensure the successful development and integration of ELN systems. Collaboration with technical teams will be a key aspect of your responsibilities, as you will work closely to drive ELN development, customization, and integration. It will be essential to ensure seamless interoperability of ELN with other lab systems such as LIMS, CDS, and SDMS. Moreover, you wi...

You will be responsible for Vial washing, Depyrogenation tunnel, and filling with isolator activity for startup and routine operation. It is important to ensure adherence to cGMP and ALCOA in your daily activities and comply with organizational policies and procedures. In this role, you will be responsible for the preparation and implementation of procedures related to qualification and maintenance activities for the Injectable facility. Reviewing, implementing, and maintaining cGMP standards in all work areas will be a key part of your responsibilities. Additionally, you will be involved in the preparation, review, approval, and implementation of Standard Operating Procedures while followin...

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.,

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

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 exper...

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 Comp...

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 clea...

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 de...

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 ...

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 do...

Job Title: Senior IT Administrator Bioanalytical Support Experience: 3-5 Years Job Summary: The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems. Infrastructure & System Support Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems. Administer Windows Server environments, Active Directory, Group Polici...