a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must. Excellent knowledge on product development and clinical studies

Provide IT support to QC, Production, AD, and Engineering departments for daily operations, audits, and validations. Coordinate and support CSV (Computer System Validation) activities for software, lab instruments, and manufacturing systems. Administer and manage Active Directory, user access controls, system privileges, and security as per IT GMP requirements. Support and manage IT infrastructure and applications in controlled environments including LIMS, CDS, EMS, BMS, SCADA, and MES. Prepare and maintain documentation like IQ/OQ/PQ protocols, SOPs, Risk Assessments, and Audit Trails. Liaise with QA and regulatory teams to ensure compliance with 21 CFR Part 11, GAMP, EU Annex 11, and Data Integrity requirements. Monitor and maintain backup, disaster recovery plans, and data archival systems for critical GMP systems. Provide first-level ERP support including user access, basic troubleshooting, and coordination with functional/technical teams for escalations.

Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines. Europe Market in Life Cycle Management

a. Should have experience in the development of Solid Oral, Liquid and Sterile Dosage forms. b. Should lead innovative or differentiated projects to support business goals. c. Should have experience in the development of potent and non-potent product. d. Excellent communication and documentation skills are must. e. It is preferred to have an experience of working with international customers. f. Should be well versed with international regulatory requirements.

Handle day-to-day IT support tickets related to desktops, laptop, mobile devices, printers, and peripheral hardware Troubleshoot and resolve issues with Windows OS, basic software applications, network connectivity, and user access Administer and manage Active Directory, user access controls, system privileges, and security Manage VLAN configuration and monitoring, supporting network segmentation and troubleshooting Perform routine preventive maintenance of IT hardware and support IT asset inventory management Coordinate with vendors for warranty replacements, hardware procurement, and service requestsSupport IT onboarding/offboarding activities such as system provisioning, email account setup, and asset allocation Provide first-level ERP support including user access, basic troubleshooting, and coordination with functional/technical teams for escalations Maintain IT documentation including issue logs, user guides, and SOPs

Machinery Breakdown Management. Operation and Preventive Maintenance. SOP Preparation and Documentation. Training and Development. Equipment Qualifications. Documentation and Data Management. Material Coordination. Attend or delegate personnel to attend machinery breakdowns promptly Monitor and verify the operation, preventive maintenance, and troubleshooting of process equipment. Responsible for qualifications (IQ, OQ, PQ), requalification, and revalidations of process equipment.

Sourcing and procurement of APIs and their impurities, and developing new or alternative vendors. API indents and planning as per the monthly production or PD schedule, coordinating with the PPIC Team and Warehouse team. Conducting due diligence audits of API facilities. Coordinating with the Regulatory and Quality Teams to arrange responses from vendors for queries and investigations. Experience in making monthly purchase statements, generating purchase orders, and work orders, as well as generating purchase performance reports on a bimonthly basis. Evaluating CDMOs for the synthesis of new APIs. Sound knowledge in vendor qualification and 21 CFR compliance, as well as licenses related to API vendors. Hands-on experience in drafting and negotiating agreements with API vendors.

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviations and improving efficiency. Conduct technical risk assessments to identify and mitigate potential issues during and post-transfer. Maintain comprehensive documentation to ensure compliance with regulatory standards (e.g., FDA, EMA, cGMP) and internal quality guidelines. Stay updated on regulatory trends and industry standards to continuously improve documentation practices and technology transfer methodologies.

a. Should have experience in the development of Solid Oral Dosage forms for general and potent products. b. Should be well versed with various regulatory guidelines. c. Should have through knowledge about fundamentals of pharmaceutical development. d. Good communication skills are must. Development of Solid Oral Dosage forms for general and potent products

Hiring Cloud Engineers for an 8-month contract role based in Chennai or Bangalore with hybrid/remote flexibility. The ideal candidate will have 8+ years of IT experience, including 4+ years in AWS cloud migrations, with strong hands-on expertise in AWS MGN, EC2, EKS, Terraform, and scripting using Python or Shell. Responsibilities include leading lift-and-shift migrations, automating infrastructure, migrating storage to EBS, S3, EFS, and modernizing legacy applications. AWS/Terraform certifications and experience in monolithic and microservices architectures are preferred Cloud Engineer, AWS Migration, AWS MGN