271 Process Validation Jobs

The position is based out of Chennai and does not offer a remote work option. The salary offered is between 5-8 lacs CTC based on validation experience. At Quascenta, we specialize in providing comprehensive validation lifecycle management software solutions. Our mission is to empower pharmaceutical manufacturing sites by offering software tools to streamline product manufacturing and cleaning processes, ensuring compliance, efficiency, and savings. Our flagship products, such as eResiduePro, eProcessPro, and eLogBook, aim to transform how companies manage their product, process, and cleaning lifecycles. With over 20 years of experience, our solutions help organizations meet regulatory requirements while enhancing operations. This full-time on-site role is for a Pharmaceutical Validation Subject Matter Expert (SME) based in Chennai. The selected candidate will offer technical support on software products like ValDoc Pro, eLog Pro, and QMS Pro to client companies. Responsibilities include assisting customers with uploading SOPs, managing qualifications in the application, executing qualification scripts (IQ/OQ/PQ) online, writing and executing test scripts, and opening bug tickets when necessary. Qualifications for the role include prior experience with QMS software, equipment/instrument qualification, and process validation. Fluency in Hindi is a mandatory requirement.,

As a maintenance engineer, your primary responsibilities will include maintaining facility and equipment, procuring engineering consumables and proprietary spares, and managing inventory. You will be responsible for performing and approving qualification studies for equipment and facilities, as well as scheduling and executing preventive maintenance programs for plant and utility equipment. Additionally, you will review and participate in process validation programs, update technical drawings such as plant layout and P & ID, and manage annual maintenance programs for utility and material handling equipment. You will also be involved in arranging instruments for plant equipment, ensuring compliance with quality documents, and meeting statutory requirements related to boiler/electrical inspections and standard weights. Your role will also involve executing plant modifications as per approved capex and plant requirements, maintaining cGMP and EHS compliance, and organizing training for department employees on SOPs, new systems, and qualifications. You will review maintenance reports and energy consumption data to identify areas for improvement and take corrective actions as necessary, in addition to overseeing the annual engineering budget. Overall, you will play a crucial role in ensuring the smooth operation and maintenance of plant equipment and facilities, while upholding high standards of quality, compliance, and safety.,

As a dedicated Downstream Process Engineer, you will be responsible for analyzing the current downstream processes to identify bottlenecks and inefficiencies. Your expertise will be crucial in implementing effective strategies to enhance process yield, purity, and throughput. Leading a team of engineers and technicians, you will provide technical guidance and support to ensure optimal performance and foster a culture of innovation, collaboration, and continuous improvement. Your commitment to excellence includes ensuring compliance with all regulatory standards and quality control procedures. By implementing robust quality control measures, promptly investigating and resolving quality issues, and developing and executing process validation protocols, you will uphold the highest product quality standards. You will also analyze validation data to ensure adherence to regulatory requirements. In your role, you will oversee the operation and process control of various equipment such as centrifuges, lyophilizers, laminar air flow systems, clean rooms, blast storage (cold rooms), CIP systems, and reactors. Monitoring OEE (overall equipment efficiencies) and ensuring the calibration of downstream processing equipment are essential tasks. Additionally, you will plan and schedule equipment maintenance to minimize downtime and optimize resource utilization while controlling operational costs. Your proactive approach will involve identifying opportunities for cost reduction without compromising quality standards. Staying informed about relevant regulatory guidelines and industry standards is imperative to ensure compliance with GMP and GLP requirements. Maintaining accurate and up-to-date process documentation, preparing technical reports, and delivering presentations will be part of your routine tasks. If you are a detail-oriented professional with a passion for optimizing downstream processes and ensuring product quality, we invite you to join our dynamic team and make a significant impact on our operations.,

A QA Manager in the pharmaceutical industry is responsible for developing, implementing, and maintaining quality assurance systems and processes that ensure products meet regulatory standards and customer expectations. he

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com

Job Description To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR. To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented. To preparation review & Approval of Quality system trend. To verify In-process Quality Assurance during production activity and sampling at different stages of processing/packing as per requirement. To review & approval of API Analytical Method Transfer Protocol/Report and method validation documents. Preparation & review of Annual Product Quality Review. Preparation, Review & Approval of Hold Time Study Protocol/Reports, and other study protocols/reports Work Experience 7-9 year Education Masters in Science or Pharmaceutical Chemistry Post Graduation in Pharmacy Competencies

Experienced in preparation,execution&review of process/cleaning validation,equipment qualification,calibration, preventive maintenance, and validation schedules. Ensures effective implementation validation master file. resume to hrd@stedmanpharma.com

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors. 4. Preparation & review of quality risk assessment reports of products & general systems 5. Conduct on the Job Training and cGMP trainings. 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records. 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification. 8. Co-ordination with the customer for compliance and day to day issues. 9. Quality agreements review and preparation. Job Qualification: Masters in Chemistry (Any specialization) Job Experience: 10 to 12 years Desired attributes: Technical / Functional: Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance). Should have sound command on the English with speaking and Writing. Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions. Behavioral: Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and quality risk management activities, conducting self-inspections, and supporting external/internal audits. You will review and approve SOPs, protocols, and reports related to validation, qualification, and quality systems, monitor and support validation activities, oversee document control, ensure timely closure of audit observations and CAPA implementation, and coordinate with various departments to ensure overall GMP compliance. Additionally, you will participate in training programs and provide QA training to cross-functional teams. SAVA Healthcare Limited (SHL) is a diversified pharmaceutical company committed to delivering quality-driven pharmaceutical solutions globally. Established in 2003, SHL has a strong presence in International Business, Animal Healthcare, Herbal Products, and Contract Research & Manufacturing Services (CRAMS). The ideal candidate for this role should have a B.Pharm / M.Pharm / M.Sc. degree with 4 to 7 years of experience in QA in a regulated pharmaceutical formulation plant. You should possess a strong understanding of GMP guidelines, quality systems, validation practices, and regulatory audits. If you are passionate about maintaining high-quality standards, ensuring regulatory compliance, and contributing to the success of a leading pharmaceutical company, we encourage you to apply for this exciting opportunity at SAVA Healthcare Limited, Surendranagar Plant, Gujarat.,

Responsible for leading production operations, coordinating production staff and equipment, ensuring product quality and profitability, and overseeing and managing the production operations involved in injectable products.

You will be responsible for conducting literature searches, gaining a thorough understanding of the product, and interpreting data for product development purposes. Additionally, you will design primary product strategies and prepare product strategies for discussion with group leaders or team leaders. Your role will involve planning and executing product development work to achieve the desired product profile, as well as compiling data. You will be required to schedule work plans in consultation with group leaders or reporting authorities to ensure timely project completion based on assigned priorities. Furthermore, you will carry out the execution and evaluation of various formulation optimization trials, process optimization trials, and data compilation. It will also be your responsibility to write laboratory notebooks and assist in documenting controlled documents, as well as compiling development data. You will be involved in the execution of scale-up, exhibit batches, characterization batches, process validation batches, and commercial batches at manufacturing locations. Additionally, you will prepare documents to ensure the smooth execution of scale-up and exhibit batches, including Justification of specification, QbD elements, MFC, etc.,

Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): - Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). - Prepare, review, and update SOPs, quality manuals, and quality policies. - Manage change control, deviation, incident reporting, and risk management systems. - Coordinate and support internal, external, and third-party audits, ensuring timely CAPA implementation and closure. - Monitor and analyze quality metrics to drive continuous improvement initiatives. - Provide training and awareness programs for QMS procedures and GMP compliance across teams. - Act as a key contact for regulatory inspections and customer audits. Validation & Qualifications: - Prepare and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and systems. - Lead process validation, cleaning validation, and computer system validation as per regulatory requirements. - Develop and maintain the Validation Master Plan (VMP). - Ensure periodic requalification and revalidation activities are performed according to schedules. - Review and approve all validation-related documents, including protocols and reports. - Ensure all validation activities comply with cGMP, data integrity, and documentation requirements. - Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes. Qualifications & Experience: - M.Pharm with 9-10 years of experience in Quality Assurance within the pharmaceutical industry. - Strong hands-on experience in QMS implementation and validation/qualification activities. - In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA). - Strong communication, documentation, and audit-handling skills. - Proficiency in MS Office (Word, Excel, PowerPoint) and quality documentation systems. - Location: Indore Benefits: - Competitive salary and performance-based incentives. - Opportunity to work on global compliance and regulatory projects. - Exposure to international audits and career advancement opportunities.,

As an Executive in MSTG at Sun Pharmaceutical Industries Ltd, your primary responsibility involves executing technology transfers to Sun/CMO sites, overseeing scale-up processes, exhibit batches planning, and process validation. This requires effective planning and efficient utilization of resources such as manpower, materials, and machinery. You will be responsible for various documentation tasks including the preparation of new production introduction forms, scale-up reports, reviewing Sun/CMO Batch Manufacturing Records (BMR), developing sampling plans, process validation (PV) protocols, User Requirement Specification (URS) preparation, and Dashboard preparation. It is essential to ensure that products are manufactured and stored in compliance with relevant documentation to achieve the desired quality standards. Additionally, your role includes reviewing and providing comments on Master Formulae (MF), Failure Mode and Effects Analysis (FMEA), Risk Assessments (RA), and protocols such as Sampling plans and Process Validation protocols to ensure regulatory compliance. You will also be involved in handling and supporting troubleshooting batches for data comparison and root cause investigation at Sun/CMO sites, investigating product troubleshooting, and overseeing timely packing operations. Furthermore, you are required to monitor and conduct pre-checks on equipment planned for use in scale-up, exhibit, and process validation batches, including equipment preparation, vial washing and dehydrogenation, Clean-in-Place/Sterilize-in-Place (CIP/SIP) systems, Programmable Logic Controllers (PLCs), and various instruments. Your role also involves supervising and conducting skid trials to enhance product development, improve processes, and address potential manufacturing constraints effectively.,

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations. Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc Must be flexible to work across any market: India, US, OAM, and EM.

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations. Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc Must be flexible to work across any market: India, US, OAM, and EM.

As a Validation Specialist at Piramal Pharma Solutions, your primary responsibility will involve preparing and updating various validation documents to ensure compliance with regulatory requirements. This includes developing Validation Master Plans (VMP), Process Validation protocols, Computer System Validation protocols, and reports. You will also be responsible for creating product matrices, Cleaning Validation/Verification protocols, qualification/requalification protocols for equipment/instruments, utilities, and facilities, as well as area validation protocols and reports. In addition to validation activities, you will be involved in quality risk assessments, review of calibration certificates, issuance and archival of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR), preparation of Annual Product Quality Review (APQR), line clearance for manufacturing, packing, and dispensing activities, sampling of bulk and finished goods, and review of production records. Furthermore, you will play a key role in managing change controls, deviations, and CAPA (Corrective and Preventive Actions), conducting complaint handling, updating departmental SOPs, providing training as per schedule, coordinating training programs with HR, and ensuring documentation management as per SOP. You will also be responsible for providing necessary documents/data to meet internal and external quality, environmental, health, and safety requirements. Moreover, you will be involved in compliance monitoring through self-inspection programs, audit compliance coordination, preparation of responses to audit reports, and execution of food/dietary supplements regulations for export markets. You will also oversee the implementation of sanitation programs, adherence to EHS norms, and various corporate initiatives. Piramal Group values equal employment opportunity, ensuring that all applicants and employees are treated fairly based on merit, qualifications, skills, and performance. As part of a globally integrated network of facilities, Piramal Pharma Solutions offers a wide range of services across the drug life cycle, making it a trusted partner for innovators and generic companies worldwide.,

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.,

As an NPD Manager, you will be responsible for leading the end-to-end new product development process, ensuring compliance with industry standards, and driving innovation by identifying new technologies and materials. You will develop and manage project timelines, budgets, and resource planning for NPD initiatives, while coordinating with cross-functional teams to monitor project progress and address risks for timely product launch. Your role will involve working closely with customers and suppliers to understand requirements, conducting market research to identify industry trends, and providing technical support during customer discussions and presentations. You will implement best practices in NPD processes and ensure all product designs meet quality, safety, and performance standards through design reviews and risk assessments. To qualify for this position, you should have a Bachelor's or Masters degree in Mechanical Engineering, Automotive Engineering, or a related field, along with at least 5 years of experience in new product development, preferably in the automotive sector. Strong knowledge of APQP, PPAP, DFMEA, PFMEA, GD&T, and CAD tools is required, as well as excellent project management, problem-solving, communication, and leadership skills. If you are passionate about driving innovation, managing projects effectively, and ensuring the successful launch of new products, we encourage you to apply for this full-time position located in Partapur (Meerut) with a salary of up to 45k. Don't miss this opportunity to join our manufacturing company and contribute to our success in the industry. Please send your resume to 8439277155 or 8279756611, or email it to hr@careerplus-jobs.com. We offer benefits such as cell phone reimbursement, health insurance, and Provident Fund, along with a yearly bonus. The work schedule is day shift, and proficiency in English is preferred for this role. Join us in person at our work location and be a part of our dynamic team dedicated to new product development and excellence in the automotive sector.,

Should have the experience in activities like QMS Activity, BMR Review, Change Control, Document Issuance, Vendor Qualification, Process Validation etc. Process validation / equipment Qualification protocol preparation and review Required Candidate profile Vendor qualification and validation

Roles and Responsibilities Responsible to design validation/ qualification strategies. Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time. Responsible to review & approve of validation /qualification protocols and reports. Responsible for day to day validation planning and execution activity. Planning, Execution & Participation of aseptic process simulation activity. Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited. Responsible to design, review, approve and implementation of departmental standard operating procedures. Responsible to review, approval and authorization of all standard operating procedure of the site. Responsible to approve specifications, standard test procedures and analytical work records. Responsible to approve master batch manufacturing records and master batch packing records. Responsible to integrate all the standard operating procedures and to design a quality system to prevent and correct quality related subjects. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. To handle the market complaints and to participate in product recall. Responsible to perform vendor audit & approve vendor for raw materials, packing materials, contract manufacturing facilities & contract testing laboratories. Responsible to finalize annual GxP / Technical training planner as per requirement and Its Plan, execution as planner. Responsible to conduct internal audit /self-inspection to ensure compliance to cGMP and other regulatory requirements. Responsible for regulatory & customer audits preparation, execution and its compliance. Responsible to review of annual product quality review, environment monitoring trends & water systems testing trends. Responsible to co -orientate with internal as well as external department personnel to maintain the CGMP environment Responsible to update & maintain online departmental documentation. To ensure supply of products and service are having acceptable standards. To approve and authorize technical agreements from customer and outside party. To approve & authorize protocol received from outside party. Responsible to approve and authorize destruction of rejected materials/batches. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. Responsible to inform top management for future requirement of departmental up-gradation necessary for the growth of organization and to meet regulatory requirement. To ensure the implementation of quality risk management procedures. To ensure that proper implementation of data integrity policies. Responsible to approve SMF, VMP, quality manual and project validation documents & release the batch after the compliance with the specifications in absence of Senior Manager QA. Desired Candidate Profile Candidate Should have experience in Injectable plant only Good Verbal & Written skill Proficient in Ms office/Excel & Word Perks and Benefits Medical Reimbursement Subsidized Accommodation for Bachelors Professional Development Paid time off Work/life Balance

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations. Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc Must be flexible to work across any market: India, US, OAM, and EM.

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects based on priority assigned. Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation of the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations. Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. In this role you will be serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarily: synthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will include: tech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Preferred Education/ Qualification B. Pharm/M. Pharm/M.Sc. Experience: 4 6 years of experience in Quality Assurance / MQA of sterile dosage manufacturing facility. Core Competencies : Technology Transfer Change Management process Risk assessments principles and tools Validation of manufacturing equipment s Drug Product Process validations Regulatory requirements Compendial Changes Technical Skills Fundamental knowledge on manufacturing and Quality control activities, such as Solution preparation, filling, terminal sterilization, visual inspection, packing, in process sampling and analysis. Technical document review skills Knowledge in change control assessment Knowledge on manufacturing process such as stopper processing, sampling and dispensing, solution preparation, Component Preparation, Filling and Capping of Drug Product Behavioral/Any Other Skills Acts Decisively: Makes decision in a timely manner based on available information Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives Critical thinking and Compliance mindset Core Responsibilities Good performance, partially independent, reviews trends and data Responsible for review of Manufacturing documents such as SOPs, Process validation, cleaning validation, cleaning process verification documents, Batch manufacturing records, Exhibit batch plan, Exhibit batch Summary Reports. study protocols and reports. Tracking of change controls, Providing QA Impact Assessment, preapproval, post approval & closure of action items. Coordinating with CFT for addressing & resolving of Review Comments for timely Closure. Review of product & process related SOP, Job aids & Forms. Review and approval of NVPC, PH and conductivity. Review and approval of APQR s. Report any non-compliance to the Supervisor Work Location Assignment: On Premise Quality Assurance and Control #LI-PFE