Process Head KAVS SPECTRONOVA TECHNOLOGIES PRIVATE LIMITED

8.0 - 12.0 years

0 Lacs

thane, maharashtra

On-site

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Balances, Equipment Sizing, and Critical Design Parameters. Additionally, you will prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. Collaboration with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation will be a crucial part of your role. Your technical expertise and leadership will be essential during project execution, commissioning, and regulatory audits. Client meetings, technical presentations, and troubleshooting activities will also be a part of your regular responsibilities, along with international travel for projects, site visits, audits, and technical review meetings. To qualify for this position, you should hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering with 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. A deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU is essential. Demonstrated leadership skills in managing diverse teams and external consultants/vendors, excellent communication, documentation, and presentation abilities, as well as the capability to handle multiple projects under strict timelines are required. A valid passport is mandatory for this role, and prior international exposure is highly desirable. In return, we offer you a challenging leadership role in global pharmaceutical projects, opportunities for international exposure and career advancement, a collaborative work environment that emphasizes innovation and compliance, as well as competitive compensation and benefits in line with industry standards. To apply for this position, please send your updated resume to suchita@spectronova.com with the subject line: Application for Process Head Pharma Projects.,

Posted 5 days ago

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Validation Testing Impetus Career Consultants

3.0 - 7.0 years

0 Lacs

pune, maharashtra

On-site

You should have knowledge of regulatory standards such as GxP and FDA 21 CFR Part 11. It is essential to collaborate effectively with developers and stakeholders to proactively understand and analyze the application requirements. Your responsibility will include creating comprehensive test cases and scenarios based on risk-based approaches, with a specific focus on critical functionalities and compliance aspects of the application. You must ensure that the test cases are traceable to the system requirements and risk assessments. Additionally, you will be required to execute IQ/OQ/PQ to validate the application. It will also be your duty to log, track, and manage defects identified during testing using test management tools. Furthermore, you will need to prepare validation documentation, which includes test scripts, validation protocols, and summary reports. The role requires the ability to work both independently and as part of a team, with a strong emphasis on quality and attention to detail.,

Posted 1 week ago

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Validation Engineer Lorhan IT

5.0 - 8.0 years

7 - 12 Lacs

Hyderabad, Mumbai (All Areas)

Work from Office

Role & responsibilities Validation Engineer • Expertise in preparing end-to-end validation documentation including protocols and reports. Collaborates closely with the testing team to ensure execution aligns with requirements. • Should utilize a risk-based approach for validation/testing. Veeva tool Preferred candidate profile

Posted 1 month ago

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Vault QA Tester Consult Asia

2.0 - 4.0 years

6 - 12 Lacs

Bengaluru

Remote

Develop and execute manual test scripts, create validation artifacts (IQ/OQ/PQ, UAT), perform dry runs and defect retests, trace requirements, collaborate with cross-functional teams, and support agile-based QA across Veeva Vault applications. Required Candidate profile Manual QA professional with 2+ years in Veeva Vault testing, experience in validation documentation, agile SDLC, pharma domain exposure. Preferably familiar with SFDC/Veeva CRM and basic automation

Posted 1 month ago

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