7 Gmp Documentation Jobs

Machine Operation Visual inspection Good Manufacturing Practices Documentation

Responsible for any packaging related activities in development lab or GMP area. Preparation of Master Packaging Card (MPC), batch packaging record (BPR) along with other GMP & Non GMP packaging documents (protocols, reports etc). Development of New change parts for blister packing. Review of executed and master batch packaging records. Taking care of GMP documentation including change control, SOP, deviation, market complain etc. Innovator pack analysis and report preparation. Preparations of departmental SOP. Initiation of Change control, Deviation and CAPA in Track Wise for Packaging related activities. Coordination with supplier for development of new/existing Packaging Materials or change parts. Coordination with Analytical, Formulation & Warehouse departments for analytical activities of Packaging Materials. Packing of Clinical/Developmental batches at pilot & formulation development lab. Periodic review of packaging materials inventory and initiating PR for the packaging material order/procurement. Preparation / Review of Master Packaging card, Bill of Materials and Batch Packaging Record. Monitoring inventory for packaging material and purchase of new materials. Preparation / Review of Specification/ STP/SOP of Packaging materials. Effective communication with Client for Packaging related matter. Reference Product pack analysis and preparation of pack characterization report. Initiation of change control, Deviation and CAPA in Track Wise for Packaging related activities. Coordination with supplier for development of new/ existing Packaging materials or change parts or new packaging instrument/ equipment. Coordination with Formulation development for Packaging related activities. Trouble shooting for Packaging related activities. Calibration & qualification of packaging related instrument/ equipment. Follow gxp (GMP, GDP, GLP, etc.) For all the processes. M. pharm/B. Pharm, candidate with IIP will be added advantage. In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limiteds investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.,

You will be responsible for supervising and guiding the IPQA team to conduct real-time monitoring during manufacturing and packing processes. Your role will involve ensuring compliance with BMR/BPR review and approvals at each stage, as well as overseeing line clearance before manufacturing and packaging activities. It will be essential to monitor critical process parameters, in-process checks, and control sampling activities including IPC, stability, validation, etc. You will be expected to ensure timely review and approval of executed batch records and logbooks, review and ensure compliance of standard operating procedures (SOPs), and maintain and control GMP documentation related to IPQA activities. Leading or supporting investigations for deviations, OOS, OOT, and market complaints, conducting root cause analysis, supporting risk assessments, and ensuring timely closure of CAPA, deviation reports, and change controls will be part of your responsibilities. In addition, you will be required to train manufacturing and QA staff on GMP, GDP, and IPQA procedures and ensure readiness for regulatory and customer audits. Your main objective will be to lead the IPQA team effectively, ensuring in-process quality assurance activities comply with cGMP, regulatory, and internal quality standards across all manufacturing and packaging operations. Your role will play a crucial part in real-time monitoring, process compliance, and product quality assurance during manufacturing.,

This role requires you to be highly skilled in technology transfer of Injectable products to manufacturing plants, including scale-up activities and demonstrating technical capabilities. You will play a key role in ensuring accessibility to both current portfolio and pipeline products. Additionally, you will share responsibility for achieving targeted product execution goals within the department/organization. Your duties will involve documentation, evaluation, and monitoring of batches at the manufacturing site. Your responsibilities will include performing product transfer activities for sterile products as assigned by the Manager/Senior Manager/Designee. You will be involved in the execution and supervision of Trial, Engineering, Scale-up, and Submission/Exhibit batches. You will compile results from scale-up trials, scale-up batches, and submission batches, drawing meaningful conclusions from the data. Moreover, you will be tasked with preparing various technology transfer documents such as Product risk assessment, Hold time study protocol & report, Scale-up batch protocol & report, among others. Your daily tasks will also encompass initiating requests for the creation or extension of Material codes, as well as working with SAP, document compliance manager, and other relevant software for documentation purposes. It is essential that you strictly adhere to the standard operating procedures (SOP) applicable at all PAR formulation sites, ensuring workplace safety. Furthermore, you will be responsible for conducting literature searches on quality management and Regulatory Guidance, as required. Collaboration with cross-functional teams to ensure timely completion of assigned activities is a crucial aspect of this role. You will be expected to develop project plans outlining timelines and target completion dates. Your support in documentation for various investigations, deviations, incidents, Out Of Specifications (OOS), Out Of Trends (OOT), and non-conformances, as applicable to R&D, will be highly valued. Ideally, you should hold a Bachelor's or Master's degree in Pharmacy, with a minimum of 4-8 years of relevant experience. Your exposure and experience in technology transfer, Manufacturing Science and Technology (MSAT), Technical services, and production for regulated markets in injectable/sterile products will be beneficial. Proficiency in GMP documentation activities, FDA regulations, and guidelines is essential. Additionally, strong communication skills, critical thinking abilities, and a proactive, innovative approach to work are key attributes for success in this role.,

The Engineering Department at Zydus Biotech Park in Changodar, Ahmedabad is looking for a qualified candidate for the position of Executive/Senior Executive - Instrumentation. The ideal candidate should hold a B.E. degree in Instrumentation and Control with 3 to 5 years of relevant experience. As an Executive/Senior Executive - Instrumentation, your primary responsibilities will include conducting preventive maintenance of plant/process equipment, performing calibrations, and ensuring the qualification of equipment and SCADA systems in compliance with 21 CFR guidelines. You will also be responsible for troubleshooting SCADA, PLC, and instruments as needed. Additionally, you will be in charge of maintaining Quality Management System (QMS) and Good Manufacturing Practices (GMP) documentation such as log books, records, status labels, preventive maintenance records, deviations, change control, and Corrective and Preventive Actions (CAPA) reports. The ideal candidate should possess knowledge of various process equipment including Autoclaves, Bio-reactors, fermenters, and Lyophilizers. Experience in implementing safety procedures and practices such as Lockout-Tagout (LOTO), proper use of Personal Protective Equipment (PPEs), and work permits system is essential for this role.,

Should have experience into sterile cleaning. Must have hands-on experience in logbook maintenance and GMP documentation. Mandatory to have ideal communication skills and good writing skills.

Location: Gurgaon Department: Research &Development (API) Key Responsibilities: Observe process in the laboratory and generate data for scale up working with chemistry teams in kilo lab and pilot plant. Design experiments using DoE (Design of Experiments) and perform reaction engineering studies for critical unit operations. Evaluate process scalability, safety, and sustainability for seamless technology transfer to the manufacturing plant. Carry out necessary process engineering calculations for scale up of unit operations. Prepare mapping, material and energy balance for the process. Develop and maintain process documentation: PFDs, P&IDs, risk assessments, scale-up reports, and technology transfer dossiers and ensure handover of the process to plant technical team. Participate in process hazard analysis (PHA), HAZOP, and safety assessments. Troubleshoot scale-up and manufacturing challenges in coordination with the production team. Evaluate and propose alternate and best process for commercial scale enhancing productivity, safety and quality. Support regulatory documentation including DMFs and QbD filings. Collaborate with engineering, production and quality assurance teams to develop and implement standard operating procedures (SOPs) and work instructions. Liaise with cross-functional teams i.e. Projects and EHS for infrastructure projects. Qualifications: B.E./B. Tech or M.E./M. Tech in Chemical Engineering Professional certification in process engineering or related areas. 2- 5 years of experience in process engineering /production department in bulk drug, fine chemicals or agro-chemicals industry. Key Skills: Familiarity with process optimization techniques, lean manufacturing principles, Six Sigma methodologies and statistical analysis. Proficiency in process analysis, process modelling and simulation software (Aspen Plus, ChemCAD , Dynochem, Visimix or equivalent) is preferred. Well versed about latest trends in manufacturing viz. Flow Chemistry, Sono Chemistry & Photo Chemistry. Excellent problem-solving and analytical skills with the ability to identify and resolve complex process issues. Working knowledge of process safety, risk assessment and compliance with regulatory standards. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Strong project management skills with the ability to prioritize tasks and meet deadlines. Interested Candidates can share their resumes on shikha.mishra@walterbushnell.com