1740 Change Control Jobs - Page 5

As a candidate for the position, your main role will involve overseeing various aspects related to Health and Hygiene policy and procedure, including housekeeping activities, pest control, and monitoring of electronic balances, Temperature, and RH in storage. You will also be responsible for the safe handling of Raw Materials (RM) and hazardous materials, as well as ensuring compliance with procedures such as RETEST procedure, FEFO/FIFO, DATA Integrity, and receipt of RM/PM. Additionally, you will be involved in activities such as dispensing RM/PM, handling Sampling/Dispensing Booth and LAF, and coordinating external calibration and preventive maintenance of equipment. Your role will also re...

As an Assistant Manager/Manager in the Quality Assurance department, your role will involve the following key responsibilities: - Review and approve Standard Operation Procedures (SOP's) for all departments, ensuring timely review and revision as per the revision date. - Review and approve various validation protocols and reports including analytical method validation, process method validation, water system validation, and equipment/instrument qualification. - Approve raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Also, approve artwork and shade cards for printed packing material. - Review and approve stability protocol...

Competent in design and planning Familiar with construction and project management processes Ability to produce detailed drawings and specifications Assist in the development of architectural projects Collaborate with senior architects and project teams Prepare and modify architectural documents and drawings Show more Show less

1. Quality Systems & Documentation: Develop, implement, and maintain GMP-compliant QMS. Oversee change control, deviations, CAPA, incident management, risk assessment, and market complaints. Ensure GDP compliance in all QA documentation, including SOPs, batch records, specifications, and MOAs. Prepare and revise SOPs, distribute and retrieve old versions, and manage documentation control. Handle QMS activities like return goods, non-conformities, and investigation reports (5-Why, 6M method). 2. Validation & Qualification: Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports. Manage process validation, cleaning validation, equipment qualification, and facility validation. Conduct ...

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...

Responsibilities: Responsible for Documentation work in QC Department Candidate must have knowledge of HPLC & GC Responsible for manufacturing the batch as per MOM or BMR. Shall maintained all records related to manufacturing Overall looking after the complete filling, packing activities and Procurement of the packing material. To ensure the compliance of safety Requirement Cleanliness Hygiene and Environment in Working Areas. Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity. Required Skills: Must be excellent in written and spoken English; net savvy and adept at computer skills Attention for detail Team player Good in communication Req...

Review and analyze candidate resumes and cover letters to identify top talent.Conduct thorough reviews of candidate qualifications and skills to ensure they meet Job Requirements.Collaborate with hiring managers to understand their needs Required Candidate profile Proven experience as a CV reviewer or in a similar role within the recruitment industry.Strong knowledge of recruitment principles and practices.Excellent communication and interpersonal skills.

Role & responsibilities Quality & Compliance Oversight Establish and maintain QMS and ISMS in compliance with ISO standards and regulatory requirements. Prepare, review, and update SOPs to reflect changes in regulations, business needs, and process improvements. Ensure SOP compliance across departments through training, monitoring, and periodic reviews. Review risk assessments and implement effective risk mitigation strategies. Oversee computer system validation (CSV) activities and review software validation documentation to ensure GxP compliance. Audit, Inspection, Deviation & CAPA Management Support and manage internal, project, and vendor audit programs. Support sponsor audits and regula...

Manager - Quality Control (Formulations) 10 to 15 years of experience in Pharmaceutical Industry especially in Formulations Unit. Should have experience in successfully handling Quality Audits. Thorough knowledge in all types of Analytical instruments, analytical methods, HPLC, Method validation and method development etc., Should possess profound knowledge and skills in OSD/Formulations products. Total Quality Management (TQM), preparation and successful implementation of SOP's. Should lead a team in QC department and responsible for TQM. Sound working knowledge in MS Office and computer skills. Responsible for day-to-day and periodical MIS reports. Coordination with Production, QA and othe...

We are looking for a proactive and detail-oriented Assistant Manager QMS to support our Engineering team and ensure compliance with global regulatory standards. The role involves managing documentation, audits, deviations, and continuous improvement initiatives in alignment with company and regulatory requirements. Role & responsibilities Responsible for incident Investigation, Root Cause Identification, impact evaluation and defining CAPA. Responsible for CAPA extrapolation, CAPA tracking and implementation. Responsible for CAPA & Change Control effectiveness check. Responsible for preparation of Quality documents. Support OOS, OOT & Market Complaint investigations. Responsible to follow an...

The Project Planner shall be responsible for integrating cost data with the project schedule to support earned value insights, cash flow forecasting and cost-to-complete assessments. The role includes maintaining alignment between the cost plan and project timeline, supporting delay impact analysis related to commercial claims and assisting in preparation of cost-loaded programs. The Planner shall work closely with the clients cost and planning teams to ensure accurate and timely reporting of cost-related planning metrics. Evaluate time impact to drive change control mechanism. Qualification : B.E./B.Tech (Civil) with NICMAR Primavera P6 and MSP Experience

Responsibilities: Maintain database on regular basis. Verify data and correct database. Review and verify the entries. Respond to queries for information and access relevant files Comply with data integrity and security policies Roles in Production Planning as well as sales as Back Office candidates. Required Skills: Must be excellent in written and spoken English; net savvy and adept at computer skills especially on ERP. Logical thinking. Organizing. Good communication. Required Qualification: - Any Computers Related

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assuran...

About The Role Job Title - Internal Audit Analyst Management Level :11 – Analyst Location:Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary :An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You ...

We are seeking a meticulous and experienced Assistant Manager Warehouse to lead and optimize warehouse operations at our OSD formulation facility, Evertogen Life Sciences. This pivotal role demands a professional who can ensure the seamless receipt, storage, and issuance of raw materials, pack materials, and finished goods, all while maintaining strict adherence to Good Manufacturing Practices (GMP), and other regulatory requirements. The ideal candidate will possess a strong understanding of ERP systems, including SAP and Inhouse Custom ERP platforms, particularly in maintaining impeccable inventory accuracy and traceability. You will be instrumental in preparing comprehensive documentation...

Responsibilities: Individually handling department & manpower. Strong leadership skills to guide, supervise work activities, and help team members develop their skills. Work allocation / Planning and Review of documents. Preparation of SOP, Specification, Standard Test Procedures (STP), Raw Data Sheet (Protocol), Excel worksheet validation etc. Preparation and review of Analytical Method Validation protocol & Report. Preparation and review of equipment qualification documents. Handling of QMS documents like Change control, Deviation, Incidents, OOS, OOT etc. To investigate, identify the root cause and troubleshoot. To maintain GLP and discipline in the QC department. Required Skills Change C...

Responsibilities: Ensuring Compliances: Quality Assurance professionals play an important role in ensuring that all processes & product comply with QMS/IMS and other relevant regulations. Quality Control: Quality Assurance professionals involved in the development, maintenance & implementation of procedures and system in QC and production. Documentation: QA professionals review and approve documents such as SOPs, batch record & other quality related documents. Audits & inspections: They conduct audits & inspections to ensure compliances with regulations & identify areas for improvements. Investigation & Corrective Action: They investigate deviations or non-conformance & implement corrective ...

Responsibilities : Handling of Change control Handling of Deviation Handling of Market Complaint Handling of OOS/OOT Handling of Corrective action and Preventive action Handling of Return goods & recall Handling of Failure investigation Quality Risk Management Review of Quality Agreement Vendor Qualification management Internal Audit management Required Skills Must be excellent in written and spoken English Net savvy and adapt at computer skills. Good in communiaation. Required Qualification: - B.Pharm/M.Pharm

Role Overview: As a QA Head at West Coast Pharma in Ahmedabad, your primary responsibility will be to lead the Quality Assurance team and ensure compliance with GMP and regulatory standards. You will oversee documentation, validation, and quality audits (internal & external) while handling change control, deviations, CAPA, and OOS investigations. Collaboration with Production, QC, and Regulatory teams will be key for driving quality improvements. Additionally, you will play a crucial role in implementing SOPs and continuous improvement initiatives. Key Responsibilities: - Lead the Quality Assurance team to ensure compliance with GMP and regulatory standards. - Oversee documentation, validati...

As a member of the Consulting organization at Oracle, your role involves ensuring the delivery of a quality, integrated software solution to clients in a timely manner and within budget. You will work closely with clients to understand and manage their expectations, as well as collaborate with Oracle and third-party vendors to ensure successful delivery. **Responsibilities:** - Manage large-scale and complex Oracle Cloud implementation and transformation projects from initiation to completion. - Develop and lead comprehensive project plans covering budget, structure, scheduling, staffing models, and resourcing while ensuring alignment with Oracle's compliance, security, and privacy standards...

We are looking for a skilled SAP CRM-C4C professional with 9 to 20 years of experience. The ideal candidate will have expertise in SAP C4C and be able to work effectively in a fast-paced environment. Roles and Responsibility Manage and implement SAP C4C solutions for clients. Collaborate with cross-functional teams to identify business requirements and develop solutions. Provide training and support to end-users on SAP C4C functionality. Troubleshoot and resolve technical issues related to SAP C4C. Develop and maintain documentation of SAP C4C configurations and customizations. Ensure data integrity and security in SAP C4C implementations. Job Requirements Strong knowledge of SAP C4C modules...

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

Role Overview: - You will be responsible for the preparation and review of master documents for sterile manufacturing in the parenteral facility. - Your role will involve preparing and reviewing protocols and reports as per requirements. - You will handle document management and preparation of BMRs, BPRs, master SOPs, etc. - Managing change control, deviations, CAPA, investigations will also be part of your responsibilities. - Providing training to subordinates, technicians, and operators in the department will be your duty. - Ensuring audit and compliance on the manufacturing shop floor. - Utilizing knowledge of kaizen and continuous improvements. Key Responsibilities: - Prepare and review ...