15 Change Controls Jobs

As a Senior Engineer in Plant Engineering at Dr. Reddys Laboratories Ltd., you will play a crucial role in ensuring adherence to Operations & Maintenance SOPs, schedules, and compliances to prevent breakdowns. Your responsibilities will include the installation and qualification of equipment, preparation and execution of various protocols and reports, breakdown and preventive maintenance of a wide range of equipment, PR initiation and vendor management for AMC equipment. Additionally, you will be in charge of executing infrastructure projects related to electrical requirements, overseeing project activities for quality, delivery, timelines, and safety, and ensuring zero incidents through compliance with work permits and safety procedures. You will also be responsible for conducting safety audits, maintaining critical spares on-site, tracking maintenance-related expenditure and budgets, ensuring equipment availability for production, and maintaining human and equipment safety in daily operations. Moreover, you will be involved in the initiation and closure of Change Controls, CAPA, Incident Investigation, SOP creation and revision for Plant Engineering, and collaborating with cross-functional teams to implement sustainability projects. To qualify for this role, you should hold a Diploma or Bachelor's degree in Electrical, Instrumentation, or Mechanical Engineering, along with a minimum of 10 years of experience in Engineering and Projects, particularly in Biologics, Formulation, Biotech, Biosimilars, Cell, and Gene therapy manufacturing. Your technical skills should include proficiency in operations and maintenance of electrical/mechanical systems, expertise in overseeing infrastructure projects, and experience in navigating audits. In addition to your technical skills, you should possess strong behavioral skills such as the ability to lead and manage teams effectively, plan and coordinate projects, communicate effectively, and demonstrate a proactive inclination towards energy-saving initiatives. At Dr. Reddys, our work culture is centered around the belief that Good Health Cant Wait. We strive to empower individuals to lead healthier lives through innovative healthcare solutions, foster a culture of empathy and dynamism, and value individual ability while promoting teamwork and shared success. If you are looking to join a dynamic team that is committed to making a positive impact on healthcare, we encourage you to explore opportunities with us at Dr. Reddys Laboratories Ltd. For more information, please visit our career website at https://careers.drreddys.com/#!/.,

As a Jr. Executive at Syngene International Ltd., you will be responsible for maintaining good aseptic behavior inside the Biologics operations facility and performing various downstream activities such as Assembly preparation, Dispensing of raw materials, Buffer Preparation, Harvest Clarification, Chromatography operation, and more. You will operate and clean downstream equipment according to standard operating procedures, monitor and control specific operations, maintain quality records, and perform in-process product sampling and storage. Additionally, you will be required to prepare and review operation-related documents, take ownership of the assigned DSP area and equipment/instrument responsibilities, initiate Complaint Slips for DSP related areas, coordinate with QA for line clearance, and ensure the process area is always ready for inspection and audit purposes. You will also support in batch execution, shipment of samples/final products, and timely closure of all documents. To qualify for this role, you should have a Masters or Bachelor's degree in pharmacy or Pharmaceutical Sciences, along with a minimum of 1-4 years of practical experience in mAbs downstream process. You must adhere to Environment, Occupational Health, Safety, and Sustainability practices, complete assigned trainings on time, comply with quality and compliance standards, and follow SOPs and operational control procedures. Furthermore, you will be responsible for reporting nonconformities and deviations, participating in investigations, CAPA, and change controls, adhering to organizational policies on EHSS, Data Integrity, and IT security, wearing applicable PPEs, and following safety protocols to ensure a safe work environment for all. Proactively identifying near-misses and potential incidents and communicating them to supervisors or line managers is also a key aspect of this role. Syngene International Ltd. is an equal opportunity employer committed to providing integrated research, development, and manufacturing solutions to various sectors. Visit https://syngeneintl.com/ to learn more about our company and our services.,

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 internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

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, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,

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 organizing production schedules to meet targets for output, quality, and yield. You will oversee all production operations to ensure compliance with SOPs and GMP standards. Collaborating closely with the Quality Control department, you will focus on continuous improvement and effective resource utilization to maintain quality parameters. Additionally, you will coordinate with cross-functional teams, particularly the Engineering Department, to ensure the production of top-notch quality products. It will be your duty to provide on-the-job training for production staff and maintain updated training records. You will be responsible for reporting deviations, conducting investigations, and implementing corrective and preventive actions as necessary. Moreover, your role will involve coordinating with QA for batch release, investigating non-conforming batches, and ensuring batch identification and traceability. Maintaining equipment/instruments calibration, practicing good housekeeping, and adhering to gowning procedures are also part of your responsibilities. In terms of qualifications, we are looking for candidates preferably with a B.Sc, M.Sc, B.Pharm, M.Pharm, or B.Tech (Chemical) degree. An experience of 8 - 10 years in the Pharma Industry or Excipient Manufacturing sector will be highly advantageous for this role. If you are a self-driven professional with a keen eye for detail and a strong background in production operations, this position at Sigachi offers a challenging yet rewarding opportunity to showcase your expertise and contribute to the company's commitment to excellence.,

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 per the need is essential. Monitoring operation, filter cleaning, filter replacement, and preventive maintenance activity of the HVAC system as per SOP, as well as checking and reviewing utility, water system, and HVAC Log books are part of your duties. It will be important to keep awareness of operational standards such as ISO 9001, ISO 14001, ISO 45001, and 13485, as well as following the regulations of various agencies like USFDA, EU, TGA, MHRA, ANVISA, WHO, Schedule M, etc. You will participate in qualification & requalification of machine/equipment and provide functional support for qualification, validation, and calibration activity. Active participation in DMS, OE, and EHS activities, as well as engagement in the process, will be required. Executing preventive maintenance plans of the respective area and ensuring good documentation and record-keeping are key tasks. Ensuring compliance of service floor activity and smooth operation and maintenance of utilities to provide uninterrupted services are also part of your responsibilities. Allocating jobs to workmen, supervising work for quality, and timely completion, as well as identifying repeated breakdowns and planning corrective actions to avoid recurrence with the engineering manager, will be important. Providing guidance and support to executives and workmen and imparting induction activity to all new joiners are also expected duties. Overall, your role will involve ensuring the proper working of HVAC systems & air conditioning units to maintain operational efficiency.,

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 change controls and performing gap analysis for new product filings. Additionally, you will be tasked with maintaining product life cycles and collaborating with cross-functional departments to evaluate, approve, and implement change proposals, deviations, and escalations. Furthermore, you will be responsible for preparing internal guidance documents to support regulatory activities within the organization. This position is based in Pune and focuses on the Canadian market, encompassing all types of dosage forms. A degree in B.Pharm/M.Pharm is required to qualify for this role.,

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 submission to regulatory agencies to ensure internal consistency and adherence to relevant guidelines, thereby promoting regulatory excellence. You will be expected to demonstrate expertise in the subject matter and relevant areas, collaborate effectively with internal and external clients, and facilitate clear and efficient communication for operational excellence. A high level of knowledge regarding country regulations and regulatory guidelines, as updated from time to time on various agencies" websites, is also required. To qualify for this position, you must hold a Master's degree in Pharma and possess relevant experience equivalent to 7 to 10 years. Strong technical data interpretation skills, interpersonal skills, oral and written communication skills, and knowledge of US Regulations are essential requirements. Proficiency in using computer applications such as Excel, Outlook, and document management systems is necessary. Additionally, the ability to work effectively in a team-oriented environment, under pressure, and within tight timelines is crucial for this role. As part of the role, you may be required to work in slots catering to different time zones as needed. The position is based in Gurgaon, Haryana, India. Join us and contribute to our global regulatory team as an Assistant Manager in Regulatory Affairs, focusing on the US market and beyond.,

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 documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

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 and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

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 records Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. Development and monitoring of corrective action plans where needed Ensuring quality support to regulatory affairs as it relates to updates/changes to market authorizations Review of all documentation (i.e. LIR, OOS, Change Controls, etc.) Ensuring quality interface with internal and external customers when dealing with activities such as service requests, issue resolution, complaints, product information, or for movement of materials, products, or process from site to site Responsible for management of regulatory authority and other external compliance audits (e.g. Customer audits) including communication, tracking and resolution of observations. Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies Responsible for Performing, reporting of observations and verification of compliance reports of internal audit

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 compliance across all functional departments. Providing adequate support to R&D teams to execute the required documents for regulatory submissions. Review of all quality documents which includes SOPs, Formats, Equipment/Instrument qualifications/ calibrations , drug excipient compatibility studies, API characterization, API solubility studies, Stability studies, Stress studies, Other studies, Method development reports, Specifications, STPs, MFR, method validations, Method transfers, PDR etc. Reviewing of LNBs, Raw data & Log books for data integrity issues.

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 Train & lead the Team Should be familiar with online GMP documentation. Should be familiar with Root cause Analysis tools. Should have in-depth knowledge on Equipment Qualification, Preventive maintenance documentation, ISO documentation, SAP knowledge. Responsible for preparation of SOP's, HVAC protocols and validation reports. Should be familiar with Change controls, Deviations, Risk assessments Should be familiar with process equipment like Reactor, centrifuge, ANFD, RCVD, Blender, sifter, multi mill, FBD etc Should be familiar with Utility equipment like Boiler, Air compressor, nitrogen plant, chillers Responsible for preparation of all types ofschedules and follow-up with user departments Responsible for Audit compliance, CAPA closing. Co-ordination with QA, production, EHS and Engineering team.