211 Pq Jobs

This Position reports to: Senior Project Lead Engineer Your role and responsibilities In this role, you will have the opportunity to support engineering activities in all types of project sizes and complexities, under the supervision of senior engineers. Each day, you will complete the tasks cost-effectively and in accordance with contract specifications, quality standards, safety requirements, and cybersecurity policies and standards. You will also showcase your technical knowledge by collecting data and supporting production of the engineering design. You will be mainly accountable for: Performing survey work, standard computations, analysis, and basic design tasks. Exercising judgment on ...

Responsibilities: Monitor manufacturing and packaging processes, including line clearance and in-process checks (IPQA) Manage documentation activities, including DOC-QMS systems, SOP preparation, deviation handling, and change control Support Technology Transfer (TT) activities by reviewing protocols, executing processes, and coordinating between R&D and manufacturing teams Ensure compliance with 21 CFR Part 11 requirements through validated software systems for electronic records and signatures Execute equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities Utilize automated quality systems and digital platforms for manufacturing documentation Mainta...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the quality control laboratory in ensuring that all testing is performed in accordance with regulat...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Responsibilities: Identify new business opportunities in the System Integration and Network Engineering services segments ofTelecommunication, IT, ITES, Smart City, FiberGrid, Digital Private Networks, Smart Classroom solution. Identify new business opportunities, EOI and Partnerships by monitoring Indian Government e-Tendering portals, PSU Portals, GeM portals & oversees portals as required. Ensuring all the PQ (Pre-qualification) and TQ (Technical Qualification) Documents are kept ready according to the RFP. Ensure all proposals meet the requirements outlined in the Request for Proposal (RFP), Request for Quotation(RFQ) & EOI (Expression of Interest).

As an experienced candidate with 4-5 years in validation documentation, you will be responsible for preparing Machine DQ, IQ, OQ, PQ, operational manuals, and all supporting documents in accordance with customer requirements. Key Responsibilities: - Minimum 4-5 years of experience in validation documentation - Preparation of Machine DQ, IQ, OQ, PQ, operational manuals, and supporting documents as per customer requirements Qualifications Required: - Relevant experience in validation documentation - Strong attention to detail - Ability to work in compliance with customer requirements The company offers the following benefits: - Cell phone reimbursement - Food provided - Internet reimbursement ...

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 10+ years of IT experience with signi...

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 5+ years of IT experience with signif...

As a Quality Control Compliance Reviewer at Amneal, you will be responsible for ensuring cGMP compliance in the QC laboratory. Your key responsibilities include: - Reviewing the completeness of analytical documents and approving the Certificate of Analysis (CoA) for Raw materials, packaging materials, In-process, finished products, stability studies for submission, validation, and commercial batches. - Performing/reviewing investigations for Quality issues such as Out of Specification (OOS), Deviations, Incidents, Corrective and Preventive Actions (CAPAs) related to laboratory. - Ensuring implementation of CAPAs recommended in OOS, Out of Alert Limits (OOAL), Incidents, and deviations in the...

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA...

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA...

Skills: GAMP 5, 21 CFR Part 11, IQ, OQ, PQ, CSV, Immediate Hiring | Computer System Validation (CSV) Pharma Industry Were looking for passionate professionals to join our team in the Computer System Validation (CSV) role. Location: Indore (M.P) Industry: Pharma Role: Computer System Validation Engineer Experience: Minimum 1 year (in Pharma domain preferred) Notice Period: Immediate Joiners to 30 days Key Responsibilities & Skills Preparation and execution of Validation Deliverables in accordance with GAMP5 and 21 CFR Part 11 guidelines. Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ, and validation of manufacturing systems (SCADA, HMI, PLC). Conduct and document Computer System...

Job Characteristics: Assists in leading software development projects through phase gate process. Writes significant amount of the code that meets project requirements and complies with documentation and design standards. Writes the standard documentation used to translate project needs into software design specifications. Assists in creating overall architecture for various software systems. Corrects defects found through QA software testing and systems testing. Assists in requirements gathering and product definition activities as projects start, and supports field test personnel after development. May coach other engineers, and occasionally provides direction to testing and lab support pe...

Your key responsibilities Technical Excellence 12+ years experience of selling cloud solutions to Enterprise customers and achieving target or equivalent experience 15+ years experience working in GPS/TMT/AMI/CHS/FS as the case may be >driving digital transformation, and/or relevant work experience (e.g., consulting, technology)OR Bachelor's Degree in Business, Technology, or related field AND 13+ years of experience working in GPS/TMT/AMI/CHS/FS as the case may be driving digital transformation, and/or relevant work experience (e.g., consulting, technology)OR Master's Degree in Business Administration Degree AND 8 + years experience working in GPS/TMT/AMI/CHS/FS as the case may be driving d...

Requisition Id 1650367 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that its your career and Its yours to build which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity Senior Consultant-FS-SaT-SaT - S&E - Corporate Strategy - Mumbai...

The opportunity We have new opportunities for ambitious individuals to join our Tax Team. You will receive extensive training and support from a variety of leading tax professionals to assist you in building a successful career in Tax service line within EY. Your key responsibilities Your client responsibilities Review of tax returns, tax provisions, and work papers. Review of audit of tax deliverables prepared by tax analysts / advanced tax analysts. Act as first level reviewers of products that are finally reviewed by the engagement teams, thus acting in the role equivalent to a counter part in the Ireland. Successfully monitor the engagement team against the plan and budget. Adhere to the...

Your key responsibilities Spanish / Portuguese language knowledge Experience in GBS set up activities such as activity analysis, cost baselining, Location assessment, Business case creation, Target Model design, etc. Working knowledge of GBS / SSC setup engagements. Know-how of the Business Transition assignments and related activities Experience / knowledge around finance functions in at least two domains Record to report (RTR), Procure to pay (PTP), Order to cash (OTC) or FP&A This includes experience around Account Reconciliations, Journals, Transaction matching, Variance analysis, intercompany and Fixed assets accounting / management Strong accounting skills and understands financial rep...

Bachelor’s degree in engineering or science discipline, or equivalent experience. A minimum of 5 to 10 years of experience in establishing and maintaining regulated supplier management systems. Experience with APQP (IQ,OQ,PQ) preferred. Technical writing of protocols and reports. Experience in ISO 9001, 13485 a plus. Engineer quality and ensure compliance for raw materials, components, finished products etc. Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage. Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized L...

Job Summary: We are seeking a detail-oriented and experienced Quality Validation Expert to lead and execute validation efforts across systems, processes, and product implementations. The ideal candidate has a strong background in testing, documentation, and compliance, and is skilled at ensuring that systems meet regulatory, technical, and business quality standards. This role is pivotal in delivering reliable, high-performing solutions through rigorous validation and continuous quality improvement. Key Responsibilities: Validation Planning: Develop and implement validation strategies, protocols, and test plans for systems, platforms, and business processes. System & Process Testing: Perform...

Description 1. Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. 2. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. 3. Individual contributor for Quality, Compliance, and Good Documentation Practices 4. Experienced in authoring review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace...

Job Title: Manager, Digital Initiatives Job Grade (refer to JE) G10 Function: Global IT Sub-function: Manufacturing IT Location: Mumbai Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job ...

Job Title: Validation Specialist Job Grade: G11A/ G10 Function: Global Information Technology Sub-function: Manufacturing & Quality IT Manager’s Job Title: Validation Lead Skip Level Manager’s Title: Head SGO IT India Function Head Title: Global Chief Information Officer Location: Mohali Areas Of Responsibility At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charg...

About the role The SRM will ensure that business stakeholders manage suppliers in line with risk appetite, optimising post-contract value, and developing a transparently sustainable supply base. The role holder will collaborate closely with senior stakeholders from across FIL to establish broad internal stakeholder relationships, drive value from, and manage risk across the supplier portfolio. These stakeholders include but are not limited to: senior executives across FIL; Supplier Relationship Managers (SRMs) across FIL; Supplier Risk Oversight (Procurement 2LoD function); Senior Procurement Category leaders; and risk partners across FIL. The SRM will be use experience of supplier risk and ...