33 Coa Jobs - Page 2

Dossier Preparation. Interact with Marketing, Quality Control, Product Development, R&D, & manufacturing units to collect necessary documents. MSDS of both Technical & formulation products. Discussions with regulatory team to improve knowledge. Required Candidate profile Must have exp in international regulatory affairs.

Position: Documentation Executive Analytical R & D Looking for candidates with 3+yrs of experience as Documentation Executive Total Experience: 3-6yrs Qualification: M Sc Location: Bangalore (Peenya 2nd Stage). Roles & Responsibilities Should have knowledge and exposure of SAP Software. Should be well versed with documentation procedures, preparation and review of Certificate of Analysis and specifications. Preparation and uploading of new finished product specifications, revision of existing finished product specifications, release of CoAs for finished products received from the units. Preparation of MSDS, work order requests, work order completion, and CoAs for samples tested for both inter-departmental and intra-departmental use. Should have good communication skills.

Studying Legal Documents and collating info in a variety of formats. Ensuring compliance with regulations set by the Cosmetics & Perfumes Regulatory Agency as country wise Keeping up to date with changes in regulatory legislation and guidelines Required Candidate profile Well versed with US FDA, EU regulatory requirements Be well versed in the preparation of MSDS, COA, PIF and CPNP files Knowledge on Indian Drug & Cosmetic mfg Act especially on Schedule S Stds & GMP.

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. General Review of plant Site Master File, layouts, and valid GMP Compliance Certificate for its adequacy to support regulatory submission. Effectively implement post-approval commitment. Preferred candidate profile Review of CMC (Chemistry, Manufacturing, and Controls) Documents Self-motivated, detail-oriented, and highly organized professional Proven ability to collaborate and communicate effectively with diverse teams Proficient in Microsoft Word, Excel, and PowerPoint Fluent in English, with strong skills in speaking, comprehension, reading, and writing. Strong technical expertise in reviewing manufacturing site documentation.

About Client Hiring for One of the topmost MNC!! Job Description Job Title: MES Camstar Developer Qualification : Any Graduate or Above Relevant Experience : 3 to 15 Years ROLES AND RESPONSIBILITIES Act as a Solution Architect for Camstar/Opcenter MES projects Lead and manage the design and development of CIO/MIO Maps and related workflows Gather and translate user requirements into functional specifications Responsible for the end-to-end implementation of MES solutions Coordinate with cross-functional teams and ensure timely delivery Manage and distribute work effectively across the development team Ensure adherence to regulatory and quality standards relevant to the industry Technical/Functional Skills Strong hands-on experience with Camstar Designer and Camstar Portal Development Expertise in COA/CIO/MIO interface connectivity Experience in large-scale, global MES implementations with full project lifecycle ownership Proven experience in the implementation of Manufacturing Execution Systems (MES), especially Camstar/Siemens OpsCenter as a COTS solution Hands-on experience with Camstar Upgrade and Factory Model Strong domain knowledge in Medical Devices and/or Pharma Manufacturing Proficient in integrating Camstar MES with external systems like ERP, LIMS, Equipment, HMI Good understanding of computer systems validation (CSV) and manufacturing validation processes Strong SQL skills Exposure to Azure Kubernetes or similar cloud-native technologies is a plusGeneric Managerial Skills Strong communication and interpersonal skills Adaptable, quick learner, and results-driven Demonstrated leadership capabilities, with experience leading project teams Ability to manage multiple priorities in a fast-paced environment Excellent team collaboration, with a focus on motivation and team development Skilled in facilitating clear and effective communication across stakeholders; Location : Pune , Hyderabad , Chennai , Bangalore CTC Range : 20 LPA TO 40PA Notice period : ANY Shift Timing : N/A Mode of Interview : VIRTUAL Mode of Work : WORK FROM OFFICE Preethi R Senior Staffing Analyst Black and White Business solutions PVT Ltd Bangalore, Karnataka, INDIA. vardhani@blackwhite.in I www.blackwhite.in

About Client Hiring for One of the topmost MNC!! Job Description Job Title: MES Camstar Developer Qualification : Any Graduate or Above Relevant Experience : 3 to 15 Years ROLES AND RESPONSIBILITIES Act as a Solution Architect for Camstar/Opcenter MES projects Lead and manage the design and development of CIO/MIO Maps and related workflows Gather and translate user requirements into functional specifications Responsible for the end-to-end implementation of MES solutions Coordinate with cross-functional teams and ensure timely delivery Manage and distribute work effectively across the development team Ensure adherence to regulatory and quality standards relevant to the industry Technical/Functional Skills Strong hands-on experience with Camstar Designer and Camstar Portal Development Expertise in COA/CIO/MIO interface connectivity Experience in large-scale, global MES implementations with full project lifecycle ownership Proven experience in the implementation of Manufacturing Execution Systems (MES), especially Camstar/Siemens OpsCenter as a COTS solution Hands-on experience with Camstar Upgrade and Factory Model Strong domain knowledge in Medical Devices and/or Pharma Manufacturing Proficient in integrating Camstar MES with external systems like ERP, LIMS, Equipment, HMI Good understanding of computer systems validation (CSV) and manufacturing validation processes Strong SQL skills Exposure to Azure Kubernetes or similar cloud-native technologies is a plusGeneric Managerial Skills Strong communication and interpersonal skills Adaptable, quick learner, and results-driven Demonstrated leadership capabilities, with experience leading project teams Ability to manage multiple priorities in a fast-paced environment Excellent team collaboration, with a focus on motivation and team development Skilled in facilitating clear and effective communication across stakeholders; Location : Pune , Hyderabad , Chennai , Bangalore CTC Range : 20 LPA TO 40PA Notice period : ANY Shift Timing : N/A Mode of Interview : VIRTUAL Mode of Work : WORK FROM OFFICE Vardhani IT Staffing Analyst Black and White Business solutions PVT Ltd Bangalore, Karnataka, INDIA. 8686127477 I vardhani@blackwhite.in I www.blackwhite.in

Preparation of Technical documents like below: COA/ Certificate of Analysis Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries

Preparation & Review of dossier in CTD, ACTD, ETCD format Preparation of dossiers of stability Data, Analytical method validation Preparing the SPC/SMPC as per country guidelines Preparation and Reviewing of documents COA as per the country guideline