PQ Jobs

Engineer (Mechanical) ISO & GMP DocumentationHalol, Gujarat Full-time On-siteAbout the Role:We are looking for a Mechanical Engineer with experience in technical documentation related to ISO and GMP standards. The role involves ensuring compliance, maintaining records, and supporting plant operations with a strong focus on safety and process improvements.Key Responsibilities: Prepare, review, and maintain documentation as per ISO & GMP requirements. Support validation and qualification activities of mechanical systems. Assist in audits, CAPA implementation, and internal quality compliance. Work closely with cross-functional teams for equipment installation, calibration, and preventive maintenance. Ensure all maintenance and modification activities are carried out safely and as per SOPs.Required Skills & Qualifications: Diploma / B.E. / B.Tech in Mechanical Engineering. 2-5 years of experience in documentation related to ISO/GMP standards (preferably in process or manufacturing industries). Strong understanding of technical drawings, SOPs, and maintenance procedures. Excellent communication and documentation skills.Why Join Us: Be part of a process-driven and quality-focused engineering team. Exposure to compliance and validation systems in a growing organization. Opportunity for continuous learning and professional development.

Roles & responsibility QA Manager is responsible for defining & establishing the quality management system. QA Manager looks after the day-to-day quality activities to ensure that employees are effectively implementing the quality system. QA Manager develops qualities policies & procedures that help in the consistent manufacture of quality products. QA Manager is also responsible for training the employees in quality practices. Draft quality assurance policies & procedures Interpret & implement quality assurance standards Evaluate adequacy of quality assurance standards Develop & help in the development of quality documents including quality manuals, SOPs, work instructions & related formats Monitor the distribution of quality documents in the company Explain the quality policy & objectives to employees & ways to achieve it Conduct regular training sessions for employees to familiarize them with current quality practices Define inspection activities for incoming, in process & finished goods. Review the implementation & efficiency of quality & inspection systems Define the agenda for internal quality audits & conduct periodic internal audits Document management review meetings & other quality assurance activities Periodic monitoring of other departments for compliance with SOPs & record keeping Collaborate with external auditors to facilitate external audits Develop, recommend & monitor corrective & preventive actions Monitor risk management activities

Prepare, review, and maintain SOPs (Standard Operating Procedures), validation protocols, batch records, and other quality documents.Ensure compliance with cGMP, FDA, MHRA, WHO, and other regulatory guidelines.Conduct document control activities, including version control, issuance, retrieval, and archiving.Support internal and external audits by providing required documentation.Assist in equipment qualification (IQ, OQ, PQ) and validation processes.Coordinate with the QA/QC team to implement corrective and preventive actions (CAPA).Maintain training records for personnel involved in quality and compliance functions.Monitor and update quality documentation systems to enhance efficiency.

We are Hiring.....Computer System Validation (CSV) Engineer. to join our team.Documentation writing, maintaining, reviewing and updating validation docLocation ( Pan India):- Baddi (Himachal Pradesh)- Halol- Vapi- GuwahatiExperience: 2+ yearsJob Summary:The CSV Engineer will be responsible for ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing/ Life Sciences environment.The ideal candidate will have experience with GAMP5, IQ, PQ, CSV, and validation of equipment.About Us: Company Name: ICS (Instrumentation & Control Solutions) is pioneered in the field of Automation, HVAC and Instrumentation providing its client with the turnkey Solution. ICS has in house capabilities to address the needs of the turnkey Solution that is process know how, the design and selection of Instruments, The selection of the Control system (PLC/ DCS), Installation of all the instruments and Control system, logic development and commissioning of the system. ICS is tied up with market leader in PLC/DCS system that is with Rockwell Automation (Allen Bradley) make PLC and DCS system and providing its client with the best of the available products and services.https://lnkd.in/evjdG84CKey Responsibilities:1. Computer System Validation: Develop, execute, and maintain validation protocols for computerized systems, including IQ, PQ, and CSV.2. Regulatory Compliance: Ensure compliance with regulatory requirements, including 21 CFR Part 11, GXP, and GAMP5.3. Validation of Equipment: Validate equipment and computerized systems.4. Risk Assessment: Conduct risk assessments to identify potential hazards and develop mitigation strategies.5. Work with manufacturing systems like SCADA, HMI, and PLC.Requirements:Education: Bachelor's degree in Computer Science, Engineering, or related field.Experience: Minimum 2 years of experience in CSV, validation, or related field.Notice Period-Immediate/30days

Handling of day to day granulations equipment's. Operating the equipment as per sop, Monitoring of clean room environment like temperature and differential pressures and RH as per SOP, PQ and PRQ protocol preparation and execution

Ensure line clearance, reviewing of BMR & BPR. Handling of shop floor QMS Documents and compliances

CAPA, Change control, Deviation, RCA. SOPs, STPs, MOA's & distribution to various departments. IQ, OQ, PQ, Production, Ensure line clearance, reviewing of BMR& BPR Handling of shop floor QMS Documents and compliances