Junior Engineer - Equipment Qualification (Pharmaceutical) PQE Group

2.0 - 6.0 years

0 Lacs

rupnagar, punjab

On-site

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Following a new opportunity, we are currently looking for a Junior Consultant: Qualification & Validation (CQV) to join our team in an onsite project at Rupnagar (Chandigarh) Location. The ideal candidate should have 2+ years of experience in a similar role and be able to review and update P&ID, prepare Qualification Documents like Validation Plan, Design Qualification, User requirement specification, Installation Qualification, Operational Qualification, Performance Qualification, System impact assessment, Functional Risk Assessment, Qualification summary report, Standard Operating Procedure (SOP), Change Control, and drafting DCS-PLC Process write up. The candidate should also be willing to travel and relocate as per project requirements anywhere in India and global locations after the project completion. An immediate joiner is required (20 Days). Location: Rupnagar (Ropar) - Punjab, near Chandigarh. As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers you the opportunity to work on international projects, enhance your skills, and engage with colleagues from around the world. If you are seeking a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.,

Posted 2 days ago

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Validation Manager Oxera Precision Tech Pvt. Ltd.

5.0 - 9.0 years

0 Lacs

karnataka

On-site

You will be working as a Validation Manager at EVOL ORTHO TECH located in Bengaluru, India. The company is involved in the manufacturing of knee orthopaedic implants for the Indian Market. Established as a greenfield project in 2025, EVOL ORTHO TECH is a Joint-Venture between a French and Mauritius Based Company. As a Validation Manager, you will report to the Quality & Regulatory Affairs General Manager and oversee a team of 3 members after ramp-up. The ideal candidate will hold a BE (MECHANICAL) degree or equivalent qualification. Your primary responsibilities will include managing process monitoring, material analysis tests, preparing qualification and validation files, handling process change requests, subcontractor change requests, and design change requests. You will also be responsible for audits, releasing production batches, document control, product release, managing the qualification process, projects, analysis of standards, and creating new tools. In terms of managerial responsibilities, you will act as the technical point of contact for the department, organize the team's work, ensure availability of resources, report malfunctions, ensure compliance with company rules and the quality system, provide guidance, training, participate in recruitment, monitor integration/training, communicate information, escalate problems, conduct interviews, and motivate the team. The ideal candidate should have knowledge of quality control, experience in design qualification, installation qualification, operational qualification, performance qualification, writing skills, proficiency in IT tools, fluency in English, project management experience, familiarity with CDSCO regulations, and skills such as rigor, organization, analytical ability, communication, good writing skills, management, leadership, conviction, and team spirit.,

Posted 6 days ago

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CSV Validation Engineer Cleanstep Pharma And Engineering Solutions

2.0 - 7.0 years

3 - 8 Lacs

Hyderabad, Pune, Mumbai (All Areas)

Work from Office

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

Posted 2 months ago

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