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2 Capa Closure Jobs

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5.0 - 9.0 years

0 Lacs

karnataka

On-site

As a Quality Assurance Specialist, your primary responsibility will be to handle Change Management, Deviations, Out of Trend, Out of Specification, and CAPA closure before the product release. This includes coordinating QMS activities in the Track Wise system and managing documents through the SAP system. It is essential to track and complete all QMS activities within the specified due date. You will be tasked with coordinating complaint investigations, managing Return Goods, and handling Recalls. Additionally, reviewing contract manufacturing and testing documents such as executed BPR and Analytical reports will be part of your duties. Your role will involve performing unplanned audits on the shop floor, monitoring the Manufacturing Process to identify root causes for product failures and cleaning incidents, and reviewing and closing Change control and related action items. Archiving of change control and other related documents will also fall under your purview. Preparation of Quality Assurance SOPs, reviewing plant SOPs, handling change control and deviations related to warehouse & SCM, and preparing and reviewing Risk Assessment reports for New Products & process change products are critical tasks that you will be responsible for. You will also be required to prepare risk assessments and declarations as per customer requirements and current guidelines. Reviewing Vendor Qualification documents, communicating with Vendors/Supply Chain Management, preparing Vendor audit schedules, implementing schedules as defined, maintaining SOP formats and Annexures, updating Approved Vendor lists periodically, and preparing and reviewing Annual Product Quality Reports and Product Quality metrics are key components of your role. Furthermore, you will review process validation protocols and reports, prepare and review cleaning validation protocols and reports, and handle any work assigned by your reporting Manager. In the absence of the position holder, operational responsibilities will be delegated to Direct reports or a designee.,

Posted 3 weeks ago

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0.0 - 3.0 years

0 Lacs

maharashtra

On-site

Trending Job Description Key responsibilities. Responsible for working with Technology Transfer, Production, and the Client to generate, revise, and approve master production records (MPRs) and any other documents associated with the commercial products in the manufacturing, e.g., SOPs, material specifications, technical reports, etc. Preparing unplanned and planned deviations for responsible processes and forming the investigation team. Collaborates with Process Development (PD), Technology Transfer (TT), Operations, Quality Control (QC), and Quality Assurance (QA) in problem-solving activities, including deviation writing and CAPA closure. Work with project and engineering teams to replace existing/modify or buy equipments for continuous improvement or capacity enhancement Functions as the technical interface between PPS-Riverview and the Client, focusing on providing technical advice and support, engineering solutions, overseeing GMP runs in the plant equipment, analyzing production data to evaluate process performance, and writing production summaries. Will require solid understanding of manufacturing processes, GMP guidelines, site and corporate policies and procedures, hands-on experience, and complete understanding of production processes in the GMP environment as laid out at PPS-Riverview. Willingness to work flexible hours and shifts when there is a need. Responsible for providing independent production support during off-hours as needed. Ability to travel as needed. Ensures process data is being updated on a monthly basis and analysis manufacturing KPI performance for improvement and discussion with the client. Takes part in Operational Excellence activities for the plant. KEY INTERACTIONS. Production Technology Transfer External Clients Project Management Education/Experience. Bachelors Degree in Chemistry or Engineering or a similar discipline is required with at least 0-3 years of relevant experience. Additional Masters or Ph.D. is preferred in lieu of some experience. Demonstrated project management and technical leadership capabilities. Confident management of internal and external stakeholder relationships. Good written and oral communication skills. Demonstrated teamwork skill and professionalism in all interactions. Proven track record of successful technology transfer. Working knowledge of process and desktop computers. COMPLIANCE. Compliance with 21 CFR - Parts 210/211, EU Directives 91/356/EEC and ICH Q7. Compliance with SOPs, batch records, forms, logs of use and Quality Agreements. Recognizes common sources of failure and improves documentation to reduce deviations and errors. Works with Operations Personnel to improve compliance. Ensures work is in compliance with all state and federal regulations, including but not limited to OSHA, GMP, DEA, FDA, etc. Assists in the formulation of corrective procedures when needed. Uses appropriate PPE while inside a manufacturing area. Assumes responsibility for safety and knows appropriate emergency procedures in case of emergency. Knows the location of SDS binders and understand how the guidelines pertain to employees. JOB CONDITIONS The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department. Physical Demands: Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer. Work Environment: Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position. Job Info Job Identification 8173 Job Category Operations Posting Date 03/30/2025, 12:47 PM Job Schedule Full time Locations Ash Stevens LLC, Riverview, MI, 48193, US,

Posted 1 month ago

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