2277 Capa Jobs - Page 23

Key skills required by this role includes: Understand Regulatory operations Gather, review and analyse data regarding the business and its operations; prepare models and process maps for improvements; and communicate findings and suggestions to key stakeholders Understanding software requirements, ability to translate business need into functional and technical requirements Skilled in documentation and timely response and sharing of information Ability to perform discussion with customer Ability to effectively report on status of work Break down requirements in user stories Ability to verify the functionality in the solution. Ability to write test cases/scripts and execute them.

Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You are looking to b...

Position: QA Executive Job Location: Nerul, Navi Mumbai Industry: Ayurvedic / Herbal Pharmaceuticals Qualification: B.Pharm /M. Pharm Designation & Salary: Commensurate with industry experience and expertise. Working Days And Time: 8:00 AM to 5 PM / 6 Days week / Sunday fixed Off. Key Responsibilities: Preparation and implementation of Standard Operating Procedures and Documentation like preparation of MFR, BMR, BPR, all types of Validation, Stability study protocols and reports. To implement and enforce cG.M.P. as per statutory requirements Giving feedback to management regarding discrepancies, deviations and any special matter. To attend external official work, seminars, meetings, discussi...

Dear Candidates, We have urgent requirements for the Quality Assurance Engineer & Quality Inspector with knowledge in quality control in offset printing, die cutting, and pasting in the food packaging manufacturing and corrugation field in Saudi Arabia. 1 Position: Quality Assurance Engineer Experience: Minimum 3+ years of experience in quality control / assurance in offset printing, die cutting, and pasting within the food packaging and corrugation industry. Roles & Responsibilities: Develop, implement, and maintain quality assurance systems and procedures to ensure compliance with company, customer, and regulatory standards. Conduct root cause analysis , investigate non-conformities , and ...

Munavvara Associates 203, 2nd Floor, Chandan Chambers, Fort, Mumbai - 400 001 www.munavvara.in Contact - 9530044005 Mail - hr@munavvara.in Dear Candidates, We have urgent requirements for the Quality Assurance Engineer & Quality Inspector with knowledge in quality control in Offset Printing, Die Cutting, and Pasting in the Food Packaging Manufacturing and Corrugation field in Saudi Arabia . 1> Position: Quality Assurance Engineer Experience: Minimum 3+ years of experience in Quality Control / Assurance in offset printing, die cutting, and pasting within the food packaging and corrugation industry. Roles & Responsibilities: Develop, implement, and maintain quality assurance systems and proced...

JOB TITLE:Mechanical Engineer Overview: We are looking for Engineer with a Mechanical Engineering background to oversee product quality, conduct inspections, and ensure compliance with industry standards. This role involves frequent travel to suppliers, manufacturing sites, and customer locations to conduct audits and resolve quality issues. Key Responsibilities: 1. Quality Control & Assurance: a)Develop and implement quality inspection procedures for raw materials, in-process, and finished forged products. b)Conduct root cause analysis (RCA) and corrective actions for quality issues. c)Monitor heat treatment, machining, and surface finishing processes to maintain product integrity. 2. Inspe...

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

HOW MIGHT YOU DEFY IMAGINATION Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What you will do The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a cr...

What you will do In this vital leadership role, you will manage and drive the qualification, validation, and compliance activities for Amgens SAP ERP systems and platforms. You will ensure that enterprise-wide ERP solutions meet regulatory requirements, industry standards, and Amgens IT-QMS policies, while building strong validation capabilities and fostering a culture of continuous compliance. Roles & Responsibilities: Lead and manage a team of validation and compliance professionals responsible for SAP ERP systems (ECC, S/4HANA, BTP, GRC, Boundary systems and related platforms). Define, oversee, and continuously improve validation and compliance strategies, aligning with CSA (Computer Soft...

Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgens Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issu...

Job Title: Integration Specialist – LIMS Job Grade: G11A/ G11B Function: Global IT/Projects Location: Baroda Key Responsibilities At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Position Summary: Integration Spec...

What you will do In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does. Data entry into Amgens Quality System of approved audit responses Audit resourcing/planning Quarterly Investigator Site audit planning including identifying audit resourc es t hrough risk assessment of audit targets on a regular basi s Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits Updating Audi t tracking and accountability t ools and distrib uting/communicatin g all ocations to the audit teams Compiling Audit reporting metrics and communication Manage Audit documentation and filing Supporting outsourced audit...

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

What you will do In this vital role, you will support the qualification, validation, and compliance processes for SAP ERP solutions and related platforms. You will work closely with senior team members, Quality, and business partners to ensure validation deliverables are executed to meet industry standards and regulatory requirements in a Life Sciences environment. Roles & Responsibilities: Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgens procedures and regulatory expectations. Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Tr...

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM 6 PM loc...

Department: R&D Quality (GPvP QA) Designation: Executive (QA Pharmacovigilance) Location: Gurgaon JOB DESCRIPTION (JD) Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc., associated with Sun Pharma Pharmacovigilance operations. Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems. Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit repo...

Walk-in drive: Senior Chemist / Junior Research Associate - HPLC Analytical Method Validations Work Location: Hyderabad Eligibility: Must have 1 to 3 Years of experience in Analytical Method Validations by using HPLC for Formulation products. M.Sc. / M-Pharmacy or Equivalent Qualification. Job Description : Analytical method validations and method transfer as per cGMP requirements for drug products. Strong experience in handling various analytical instruments like HPLC, UPLC, UV and Dissolution USP type-I and II and type-IV. Dissolution, Assay and Related Substances method validationand method development of finished products like Tablets, Capsules, Pellets, oral suspensions and Injectables ...

The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also support various aspects of the product lifecycle including complaint investigations, expansion and transfer of products to new manufacturing sites, inspection readiness activities, and platform support and improvements. Responsibilities: Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities. Ensure program al...

Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per d...

Role & responsibilities Location: Bidar, KA Role: Sr QA Lead JOB DESCRIPTION: 1) Handling of Quality management system. 2) Monitoring Process validation program. 3) Handling of customer and regulatory audits. 4) Monitoring Equipment Qualification program. 5) Coordinate with cross functional team to provide audit response to customer and regulatory agencies. 6) Conducting internal audits as per schedule. 7) CAPA effectiveness verification. 8) Conducting Quality review board meetings and management review meetings as per schedule. 9) Monitoring Equipment cleaning program. 10) Providing necessary documents to address Regulatory Queries, amendments, annual updates and regulatory filings and CMC ...

Head of Lab Operations / General Manager Base: Hyderabad | Covers: Hyderabad, Vizag, Bengaluru, Mumbai & other hubs Reports to: COO Mission: Deliver fast, reliable, frugal operations across sitesmax uptime, low TAT, zerocompromise quality. Key Responsibilities (essentials) Own TAT, capacity/shift planning, hubandspoke load balancing. Ensure analyzer uptime via PM calendars, spares, and vendor SLAs. Drive cost/test: reagent rental optimization, batching (where safe), wastage control, inventory pars. Enforce SOPs/IQC/EQA schedules; auditready documentation and CAPA tracking. Hire, train, crosstrain technologists; run daily huddles and safety culture. Orchestrate courier/coldchain windows; moni...

Job Responsibilities & KRA's for Quality Head- Bicycles: SQA Take decision in case of any non-conformity in the product either received from supplier or dealer (accept/reject/deviation) considering material urgency/ cost implication. Ensure monthly worst supplier reporting from SQA and ensure supplier process audit plan is prepared and audits are conducted as per plan. Conduct monthly worst supplier meetings with supplier team and review audit observation and closures by suppliers through CAPA. Workout New supplier selection process and approval mechanism based on request from Purchase/internal team. Plan and conduct trainings for supplier teams and internal teams on quality tools eg- 7QC, A...

Quality Inspector Power Quality Products The opportunity Its an opportunity to work with diverse materials and people, exposure to variety of global and local suppliers and cross function teams, Lot of learnings on materials specification, engineer , quality requirements of a power quality product (Capacitors and associated equipment), greater opportunity to put your thoughts and creativity for continuous improvement, also exposure to digital solutions (manufacturing , supplier management) How You'll Make An Impact Ensuring Quality requirements are met for the incoming materials (Raw materials, Bought out ). Quality Documentation for incoming materials. Use of SAP-REIWA for material manageme...

Job Description Responsible for routine operations of power distribution system, D.G. Sets, HT Breakers, HT Yard, LT Breakers, switch gears and distribution panels. To Perform the preventive as per schedule and predictive maintenance as when required for all Electrical power distribution equipment's. To attend the breakdown maintenance of all Electrical power distribution equipment's like LT panels, D.G. Sets, HT Breakers, HT Yard, LT Breakers, and switch gears To attend the breakdown maintenance of Chillers, Air compressors, Boiler control system, Water system, cooling towers, and other utilities. To record daily log sheets related to Power distribution system SOPs and as instructed by supe...