64 Change Controls Jobs - Page 3

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in ...

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corp...

Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc., To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements. To conduct/participate internal quality audits & regulatory / customer audits. Communications with External Vendors/customers for relevant information/documents Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities. Review of development and commercial batch documents

As a Supervisor at Sigachi located in Dahej, you will play a crucial role in ensuring the smooth production operations in line with GMP standards. Sigachi, a renowned manufacturer of Excipients for Pharma, Nutra, and food industries, has been a key player in the market since its inception in 1989. With multiple facilities in Telangana and Gujarat, Sigachi has solidified its position as a leading producer of Microcrystalline Cellulose globally. Operating under various certifications like EXCiPACT GMP, SGMP, HACCP, EDQM CEP, and ISO 9001:2015, Sigachi has built a reputation for delivering high-quality products across continents. Your primary responsibilities will include planning and organizin...

As a Shift Operation Engineer, your responsibilities will include handling the shift operation and completing related documentation as required by SOP. You will be responsible for achieving targeted production, ensuring smooth, efficient, uninterrupted, and trouble-free operation and maintenance of the water plant, HVAC, and other utility equipment as per SOPs. Implementing best practices to comply with quality, safety, and regulatory requirements will be crucial in this role. Your tasks will also involve preparing, ensuring, and monitoring compliance of SOPs and related documentation of the engineering department. Initiating Change controls and Deviations, CAPA in the electronic system as p...

As an Assistant Manager/Manager in Regulatory Affairs with 7-11 years of experience, you will report to the Head of Regulatory Affairs and be responsible for handling regulatory activities for the Canadian market. Your primary focus will be to develop regulatory strategies for submissions, assess changes, and manage the product life-cycle across various dosage forms. You will also be involved in compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS), as well as conducting module-wise document reviews. Your role will encompass reviewing documents and artworks to ensure compliance with eCTD (electronic Common Technical Document) guidelines, as well as overseeing chang...

You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Your tasks will include reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. It is essential to critically review documentation intended for su...

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary docume...

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits a...

Role & responsibilities: : Experience in Canada Market Dossier compilation (Injectable & OSD dosage forms) & knowledge of regulatory procedures and guidelines (ICH). Planning, execution and assessment of product life cycle management activities and strategies (LCM & Variation) Review technical documents like Protocols, API & Drug product technical packages, Change Controls etc and prepare technical documents to support regulatory submissions Knowledge in query response to agencys questions within assigned timelines ** Canteen & Transportation Facilities are Provided

Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc. Responsible for review and approval of all continual improvement projects affecting quality at a site Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of r...

Handling, storage and retrieval of all the documents pertaining to facility on operation of the functional departments. Deploying Good Documentation Practices throughout all the functions. Allotment of reference numbers, Formatting, distribution, control, revision, retrieval and storage of all master documents. Maintaining of master list of documents. Maintaining online documentation. Issuance of Formats, LNBs & Log books to all departments. Preparation of QA&RA SOPs. Monitoring of Instruments and Equipment calibrations. To involve internal quality and regulatory compliance audits across all the functions. Handling of Training Records across all the functional departments. Monitoring for com...

Job Description : Business: Pharma Solutions Department: Engineering Location: Digwal Travel: NA Job Overview To maintain the GMP & EHS Documentation related to E&M Key Stakeholders: Internal Production, QA, EHS Key Stakeholders: External Regulatory, Customer Reporting Structure AGM - E&M Positions that report into this role Executive/ Sr. Executive / Dy. Manager Experience 12 years and above Job Description: Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Tra...

Role & responsibilities The Deputy Manager - CSV will be responsible for overseeing the validation of computerized systems in manufacturing and laboratory environments, ensuring compliance with regulatory standards and best practices. This role requires strong technical knowledge, attention to detail, and effective communication skills to collaborate with various stakeholders. Desired Candidate Profile : The candidate must have a minimum of 5 years of experience in the pharmaceutical industry, with at least 5 years focused on end-to-end Computerized Systems Validation (CSV) for manufacturing and laboratory equipment. Detail-oriented, with primary responsibilities including authoring in-house...