5 Glp Compliance Jobs

We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization You need to co-ordinate and follow up with external labs including training of their staff. You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. You will have to participate in handling and resolution of laboratory non-conformances with related documentation You will be responsible for analytical methods and process compliance as per quality assurance requirement. Qualifications Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies Efficient in MS Office, Word/Excel/PowerPoint functionalities Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. Ability to understand analytical methods defined by global and local bodies Ability to resolve analytical issue associated with different product matrix. Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills Systematic approach and strategic thinking Possess excellent interpersonal skills, communication, coordination, and time-management skills Ability to independently handle teams Excellent oral/written communication and articulation skills Passion for people development Ability to prioritize work and change focus quickly Ability to delegate effectively

You will be responsible Analytical method development and validation of injectable, Inhalationsand Nasal products. You will be responsible to perform the Drug Master File/Literature review and procure the relevant columns and standards in order to initiate the analytical method development. Stay updated with the latest literature and industry developments in the field. You will be responsible to execute analytical activities as per defined procedures, document the data and send the respective record of analysis to group leader/analytical expert for the review and release in order to provide the approved results to formulation team. You will be responsible for analytical method development for drug products for various tests mentioned in the specification in order to analyse the product development batches for the prototype screening. You will be responsible for analytical method validation activities at the manufacturing sites providing method development reports to verify the validation parameters and ensure the execution of method validation as per the regulatory requirement in order to provide the authentic analytical validation report for the regulatory filing. You will be responsible for analytical method transfer to plant locations successfully in order to train the Quality Control (QC) team on the methods for the Exhibit and commercial batch analysis at plant. You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results. You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy. You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions. You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. Qualifications Educational qualification: Masters in Science/ Organic chemistry/ Pharmaceutical Sciences Minimum work experience: 10 years of experience in analytical method development Skills & attributes: Technical Skills Have work experience on Process scale up of Inhalation, Nasal and Injectable Products. Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Understanding on Abbreviated New Drug Application (ANDA) filing requirements. Experience in Process Optimization (Manufacturing) and Technology Transfer. Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis. Proven experience in method validation and documentation in compliance with regulatory requirements. BehavioralSkills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.

Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 23 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control Support Analyst ,Application Admin ,IT Support, GLP Compliance ,Application Support ,SOP ,System Validation

Role Responsibilities: Operate HPLC, ELISA Reader, and microscopy instruments Perform colorimetric and spectrophotometric assays Maintain GLP-compliant documentation and lab practices Support QC testing in biochemical and hematology assays Key Deliverables: Accurate analytical test reports 21 CFR-compliant chromatography data Routine calibration and maintenance logs QC records supporting GMP batch release

Role Responsibilities: Operate HPLC, ELISA Reader, and microscopy instruments Perform colorimetric and spectrophotometric assays Maintain GLP-compliant documentation and lab practices Support QC testing in biochemical and hematology assays Key Deliverables: Accurate analytical test reports 21 CFR-compliant chromatography data Routine calibration and maintenance logs QC records supporting GMP batch release