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Computer System Validation Training @ Gratisol Labs An Upgrading Career For Experience Pharma Professionals. Gratisol Labs Providing Pharmaceutical Computer System Validation For Experience Pharma Professionals. The course provides compliance with GMP requirements and specifically designed for professionals. By using a risk-based approach and in-depth understanding of various CSV methodologies including GAMP5 guidelines, Validations, Annex 11 and the CFR Part 11. Computer system validation is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record. Computer System Validation Modules: • MODULE 1: FDA Regulatory Module. • MODULE 2: Development of Validation Documents. • MODULE 3: Documenting CSV QUALITY EVENTS. Computer system validation deliverables • Validation plan • System risk assessment report • User requirements specification • System configuration specification • Test plan • Installation Qualification (IQ) testing and results • Operation Qualification (OQ) testing and results • Performance Qualification (PQ) testing and results • Optional) Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11) • Validation traceability matrix • Quality assurance review • Validation summary report • Review of Standard Operating Procedures (SOPs) • Technical support Eligibility: • Bachelor’s degree in a Life Sciences or Information Technology (IT) discipline or equivalent experience preferred. • Minimum of two (2) years of relevant experience in Pharmaceutical Indsustry or quality required. • GxP hardware and/or software experience preferred. • Knowledge of 21 CFR Part 11 / Annex 11 regulations preferred. • Knowledge of cGMP and validation regulations and requirements. • Knowledge of GMP, GLP, GDP, pharmacopoeial and regulatory requirements preferred. • Detail oriented with strong written and verbal communication skills. • Ability to work independently, within prescribed guidelines, or as a team member. Venue: Gratisol Labs, KVR Enclave,2nd Floor, 207, Ameerpet, Hyderabad. Land Mark: Gurudwara Contact - show contact info / show contact info

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** Expert in Remote desktop configuration ** IT technical support officers monitor and maintain the computer systems and networks of an organisation. You will be installing and configuring computer systems, diagnosing hardware and software faults and solving technical and applications problems, either over the phone or in person. In your role as technical support you'll cover one or more areas of expertise, depending on the size of the organisation. Organisations increasingly rely on computer systems in all areas of their operations and decision-making processes. It's therefore crucial to ensure the correct running and maintenance of IT systems. Job titles may vary. Alternatives include: applications support specialist help desk operator maintenance engineer technician. You can also work within first or second-line support. The work is as much about understanding how information systems are used as applying technical knowledge related to computer hardware or software. Responsibilities I'll be responsible for the smooth running of computer systems and ensuring that users get maximum benefits from them. Individual tasks vary depending on the size and structure of the organisation, but i'll need to: install and configure computer hardware operating systems and applications monitor and maintain computer systems and networks talk staff or clients through a series of actions, either face-to-face or over the phone, to help set up systems or resolve issues troubleshoot system and network problems, diagnosing and solving hardware or software faults replace parts as required provide support, including procedural documentation and relevant reports follow diagrams and written instructions to repair a fault or set up a system support the roll-out of new applications set up new users' accounts and profiles and deal with password issues respond within agreed time limits to call-outs work continuously on a task until completion (or referral to third parties, if appropriate) prioritise and manage many open cases at one time rapidly establish a good working relationship with customers and other professionals, such as software developers test and evaluate new technology conduct electrical safety checks on computer equipment. WhatsApp Number is +91 show contact info

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Damaged Body Repair, Camera Malfunction Repair, Keyboard Replacement/Software Issue Fixing. MacBook Repair, Shop No 24, Ground Floor, Om Heera Panna Mall, Oshiwara, Andheri West, Mumbai:400053, call us on +91- show contact info,022-4972344 http://www.macbookrepairmumbai.com/ https://www.google.com/maps?cid=9971305313660161977

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