234 Gdp Jobs - Page 8

B.Sc. / M.Sc. - Chemistry with 02 to 03 years of experience in Pharmaceutical Industries (API – Intermediates). Must be aware of the working conditions in an API / Intermediate unit. One who is able to handle all pharma reactors. Equipment handling. Required Candidate profile Monitoring production planning to meet production targets. To ensure that the production records are maintained and recorded at the time of performance. Knowledge of GMP & GDP procedure to follow. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

Key Responsibilities: Coordinate and supervise the receipt, sampling, and storage of raw materials. Ensure proper documentation and labeling of all RM containers as per SOP. Maintain records of raw material specifications, COAs, MSDS, and vendor documents. Conduct or coordinate sampling of incoming raw materials in compliance with GMP and SOPs. Follow up with the Quality Control (QC) team for timely testing and approval/rejection of raw materials. Monitor inventory levels and notify procurement for reordering when required. Ensure proper segregation and identification of quarantined, approved, and rejected materials. Assist in supplier qualification and raw material risk assessments. Partici...

Key Responsibilities: Coordinate and supervise the receipt, sampling, and storage of raw materials. Ensure proper documentation and labeling of all RM containers as per SOP. Maintain records of raw material specifications, COAs, MSDS, and vendor documents. Conduct or coordinate sampling of incoming raw materials in compliance with GMP and SOPs. Follow up with the Quality Control (QC) team for timely testing and approval/rejection of raw materials. Monitor inventory levels and notify procurement for reordering when required. Ensure proper segregation and identification of quarantined, approved, and rejected materials. Assist in supplier qualification and raw material risk assessments. Partici...

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and labo...

Operate and monitor compression machines (e.g., Cadmach - ACC). Ensure smooth execution of batch production as per BMR/BPR and SOPs. Carry out in-process checks (IPC) like weight variation, hardness, thickness, friability, etc. Perform machine changeovers, cleaning, and line clearance. Maintain and update Batch Manufacturing Records (BMRs), logbooks, equipment usage logs. Adhere strictly to cGMP, GDP, and safety norms. Participate in audits (internal/external) and handle compliance requirements. Collaborate with QA, maintenance, and validation teams. Report deviations, breakdowns, and implement corrective/preventive actions (CAPA). Suggest and implement process improvements for yield and pro...

Role & responsibilities Routine activities of Production department Batch processing CGMP GDP SOP Preferred candidate profile Relevant experience from Pharmaceutical and Chemical industry. Must have cGMP experience.

QC Reviewer / Sr. Research Associate: Role & responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation reports. Check instrument calibration records and ensure compliance before reviewing analytical results. Identify and report any data discrepancies, deviations, or non-conformities. Review and verify entries...

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance ...

Roles and Responsibilities 1. Responsible for production machinery operation and maintenance activity 2. Checking the day logbooks and maintain all data in control. 3. Train the new operators for the filling machine and sterilizers. 4. co ordinate with supplier for spares development and final design. 5. Responsible for Mould change over in FFS (Form Fill Seal) and ISBM (injection stretch blow Mould) machine as per product size. 6. Responsible for product targets,rejection control and yield maintenance at filling stage for each filling lines. 7. Responsible for production sterilizer maintenance and assist in operational problems. 8. Responsible for maintenance of production vessel and autocl...

Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with intern...

Position : Assistant Manager- Production Location : Dahej Experience : 4-8 Years CTC Range : 5-9 LPA 1. Production Operations: Check and verify labels of raw materials, packing materials, and solvents before usage. Maintain appropriate storage conditions of raw materials and intermediates in the plant. Ensure adherence to process conditions during batch processing as per BMR (Batch Manufacturing Records). Take instructions from Shift In-charge / Managers for batch charging and monitoring. Report any deviations or discrepancies in plant/process to the Shift In-charge immediately. Complete assigned production tasks within the stipulated time. Maintain environmental conditions in the Production...

The ideal candidate must have prior experience in pharma warehouse management, with a strong understanding of compliance, inventory control, and efficient warehouse practices at our ALC Baruipur facility.

Roles and Responsibilities Manage inventory control processes, including GRN, GDP, and stores management. Ensure accurate stock records through regular audits and reporting. Coordinate with suppliers for timely delivery of materials and equipment. Conduct physical counts to verify inventory accuracy and identify discrepancies. Implement quality control measures to maintain high standards in store operations.

Harman Finochem is looking for a skilled Technology Transfer Executive to join our team. In this role, you'll be crucial in facilitating seamless technology transfers, ensuring robust documentation, and maintaining compliance with key regulatory guidelines. If you have hands-on experience with process validation, cGMP, and possess strong analytical and communication skills, we encourage you to apply! Key Responsibilities Documentation & Compliance: Prepare and manage essential documents such as BMR (Batch Manufacturing Record), Process Validation Reports, Stability Protocols, and Sampling Plans . Initiate and ensure the proper closure of Change Controls and Deviations in accordance with GMP ...

The Life Sciences Senior system engineer is an integral member of the Life Sciences Hub team, who reports to LE/PE and undertakes the Design, Implementation, Internal testing and Factory acceptance test of respective Process/Function area for Process Systems and Solutions (PSS) projects. The senior system engineer in Life Sciences Hub: Supports Lead engineer as Area/Sub lead for the Medium to Large size projects. Has good knowledge of the DeltaV system and exposure to S88 architecture . Has hands on experience on Batch process Applications e.g- in Biotech, Pharma, F&B, Terminal automation etc. Has Design and configuration experience of Medium to Complex Equiment modules/sequences . Understan...

The Life Sciences Senior system engineer is an integral member of the Life Sciences Hub team, who reports to LE/PE and undertakes the Design, Implementation, Internal testing and Factory acceptance test of respective Process/Function area for Process Systems and Solutions (PSS) projects. The senior system engineer in Life Sciences Hub: Supports Lead engineer as Area/Sub lead for the Medium to Large size projects. Has good knowledge of the DeltaV system and exposure to S88 architecture . Has hands on experience on Batch process Applications e.g- in Biotech, Pharma, F&B, Terminal automation etc. Has Design and configuration experience of Medium to Complex Equiment modules/sequences . Understan...

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance ...

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other re...

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...

Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise. Experience working in a GMP environment, 7+ years in an IT Systems Role. Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management. SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP) Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements. Comprehensive understanding of Quality Management processes, regulatory compl...