5.0 - 12.0 years

5 - 12 Lacs

Baddi, Himachal Pradesh, India

On-site

To develop, ensure, implement and maintain a GxP compliant Laboratory systems. To ensure training and effective implementation of current Good Laboratory Practices. To establish and ensure analysis, approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated Pharmacopoeia / In house method for Oral Dosages and LVP facility. To ensure that the appropriate validations, including analytical procedures, and calibrations of equipment are done. To Ensure the Maintenance of the Department, Premises and Equipment. To ensure all necessary testing and stability studies are carried out for Oral Dosages and LVP facility as per the approved spe...

Posted 3 months ago

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Senior Manager - IT Quality Amgen Technology Private Limited

10.0 - 15.0 years

3 - 10 Lacs

Hyderabad / Secunderabad, Telangana, Telangana, India

On-site

Focus Areas Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification. Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery. Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement. Responsibilities Strong project management skills with experience ...

Posted 3 months ago

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Business Analyst profile with GxP and GMP V Soft Consulting Corporation Private Limited

4.0 - 6.0 years

4 - 8 Lacs

Remote, , India

On-site

KEY RESPONSIBILITIES The incumbent will work closely with the Corporate Quality Assurance teams under the supervision of the Digital Business Partner, leading articulation of key technology and digital requirements and ensuring successful rollouts. More specifically s/he will lead the following responsibilities: Business Analysis: Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase. Collect data, analyse & define the business and user requirements. Analyse business problems and facilitate in IT solution evaluation. Work closely with managers and end users to have buy-in for the proposed solution. Creating a detailed bus...

Posted 3 months ago

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Executive IT (GMP Operations) || (Karakhadi Plant) Vadodara Alembic Pharmaceuticals

3.0 - 5.0 years

3 - 8 Lacs

vadodara

Work from Office

We are looking a skilled and motivated Executive IT (GMP Operations) with 3 to 5 years of experience for our Manufacturing Unit (Karakhadi Plant) The candidate will handling IT systems within GMP-regulated environments and support QC and Manufacturing IT operations with a strong focus on compliance, data security, and system integration. Key Responsibilities: Oversee IT GMP operations for QC and Manufacturing systems. Manage user access , data security , domain controllers , and backups . Integrate manufacturing equipment with IT systems and ensure GxP system compliance. Administer QC and Manufacturing applications like Chromeleon, Empower , etc. Operate and support SCADA, HMI , and other ma...

Posted Date not available

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