Role & responsibilities 1. Prepare standard documents (SOP, batch records, specs etc) adhering to policies, procedures and regulatory requirements. 2. Responsible for sharing of periodic review reports to stake holders. 3. Responsible for carrying out all the tasks assigned by the reporting manager. 4. Expert in using Track wise digital or any Electronic Documentation Management System. 5. Responsible for carrying out admin role as per the requirement in support to stake holders. 6. Knowledge of quality systems and GMP regulations 7. Excellent verbal, organizational, written, and interpersonal skills required. 8. Sound keyboard skills and knowledge of Microsoft Office applications including Word, Outlook, Excel and PowerPoint. 9. Ability and desire to work in a team-based setting. 10. Ability to work independently and to continuously improve Quality processes. Preferred candidate profile B.Pharmacy, M.Pharmacy , M.S. degree in Chemistry, Microbiology or related field. 1 to 3 years of experience in the pharmaceutical industry (commercial manufacturing sites within API or DP), with experience in Quality Assurance. Experience of Shared Services strongly preferred (dedicated unit for the execution of specific operational tasks for the multiple business units within the organization). Strong knowledge of the pharmaceutical industry regulations applicable to API and Drug Product manufacturers. Good understanding on Good Manufacturing Practices, with practical experience on the field. Expert in using Track wise digital or any Electronic Documentation Management System
Role & responsibilities Writes, reviews, supports and executes all system lifecycle documents (URS, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, Data Integrity Evaluations, Trace Matrix, SOPs, Validation Summary Report, etc.). Work closely with project stakeholders (IT, System Owner, QA, Cyber Security) to effectively and efficiently implement new systems, system upgrades, or system modifications. Writes and Reviews Operational SOPs and Processes Gather and control Software and Hardware Inventory lists. Develops and manages project schedules to drive efficient projects executions. Manages consultants to ensure that project timeline, budget, and quality are maintained Manages CSV projects under a GAMP lifecycle framework. Conducts data integrity and information assurance evaluations and enforces the required controls. Supports client and regulatory audit activities. Assist in development, implementation, and enforcement of computer system validation, information assurance, cyber security, and data integrity policies and practices. Perform periodic reviews of the validated computerized systems. Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation. Work closely with cyber security team Performs routine backup analysis and trending Perform Infrastructure Qualifications Perform Data integrity Reviews Perform Excel validation Perform other duties as assigned. Preferred candidate profile At least 1-3 years of Computer System Validation experience required. Experience in pharmaceutical industry is preferred. Minimum BA / BS or relevant work experience in information systems, information assurance, Analyzing, science or business. 1-3 years of experience writing, reviewing and executing computer validation documentation Basic understanding of computer networks, protocols, operating systems, as well general information and operational technology stacks. Basic understanding of information assurance and cyber security. Experience in disaster recovery, identity and access management, asset management, patch and vulnerability management, and cyber incident response preferred. Experience in Data integrity Reviews, Excel validation or infrastructure validation Thorough understanding of the principles of computer systems validation, system development lifecycle (SDLC) methodologies and testing best practices. Knowledge of cGMP, GDP, GAMP, 21CFR Part11, ALCOA+, and NIST CSF and other industry best practices. Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. Strong communication and interpersonal skills Excellent oral and written communication skills. Perks and benefits