Job Description Responsible to operate the machines Responsible for cleaning and sanitization of visual inspection and Packing area. Responsible to all packing related activities. Responsible to fill the log of general area as per SOP and work execution. Responsible to attend the training as per schedule and to ensure the training as per TNI. Responsible to follow the preventive maintenance schedule of machine. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in visual inspection and Packing area. To follow the cGMP, Good Document Practice, and discipline in the department. Responsible for line clearance activity before commencing the operations. Qualifications ITI / Diploma / B.Sc Show more Show less

Description JOB DESCRIPTION The role involves ensuring CGMP compliance and supervising overall production activities of manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. Essential Functions Responsible for preparation, review, revision, control, and implementation of standard operating procedures . Responsible for preparation & review of the master documents of production . Responsible for preparation and review of Protocols and reports based on the requirements. Responsible for Document management like BMRs, BPRs, Master SOPs etc.. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc.. Responsible for line clearance activity before commencing the operations like manufacturing, filling, capping & packing operations . To generate general purchase indent for departmental general items. Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials. Responsible to prepare daily production report as per the production achieved. Responsible to ensure that all equipment’s and lines are in validated and calibrated status. Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same. Ensure the compliance & discipline . Responsible to makeshift schedule . Responsible to check that all the records and logbooks related to manufacturing, filling and sterilization of equipment’s Additional Responsibilities Responsible to give training to all the subordinates, technicians, and operators of the department. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Responsible to attend the training as per training schedule and to ensure training as per TNI. Education QUALIFICATIONS Bachelors Degree (BA/BS) B. Pharm - Required Master Degree (MS/MA) M. Pharm - Preferred Master Degree (MS/MA) M. Sc. - Preferred Experience 12 years or more in 12 - 16 Yrs Skills: Specialized Knowledge: Licenses: Show more Show less

Job Description JOB DESCRIPTION Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills Qualifications B. Pharm / M. Pharm About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. Show more Show less

Job Description Design and specify process equipment systems for pharmaceutical manufacturing plants, ensuring alignment with the project goals and regulatory standards (e.g., GMP, FDA, EMA). Select appropriate equipment, considering factors such as material compatibility, process requirements, automation, and cost-effectiveness. Develop equipment specifications, datasheets, and technical documentation for procurement and installation. Having hands on experience for installing isolator-based filling line. Line manufacturer is Bausch + Straubel, Syntegon, Steriline. Lead or support the execution of process equipment projects, including installation, commissioning, and qualification. Develop project plans, timelines, and budgets for equipment-related projects, ensuring the completion of all milestones on time and within scope. Coordinate with external vendors, suppliers, and contractors to ensure timely delivery and installation of process equipment. Oversee the installation and commissioning of new equipment and systems, ensuring smooth integration into existing operations. Show more Show less

Job Description KEY ACCOUNTABILITIES : End-to-End Supply Chain Management: Manage the supply chain processes from sourcing, storage, inventory management, to distribution for the India business. F reight & Logistics Management : Oversee the inward and outward transportation of products across the domestic market for Hospital, Ophthalmology, Oncology, CNS, and Diagnostics Divisions, ensuring compliance with temperature requirements (Minus 20°C, +2°C to +8°C, +15°C to +25°C). Vendor Management: Build and maintain relationships with supply chain partners, ensuring optimal performance and compliance with SLAs. Team Leadership: Lead and mentor a team that handles customer code creation, Goods Receipt Note (GRN), material movement, and related operations. Demand Review & Inventory Management: Collaborate with key stakeholders to manage inventory levels and demand forecasts to prevent stockouts or excess inventory. CFA & Warehousing Operations : Oversee the management of CFAs (Carrying and Forwarding Agents) and warehousing operations to ensure efficient product movement and storage. Super Stockist Operations: Manage and optimize operations with super stockists for product distribution. SOX Compliance: Ensure adherence to Sarbanes-Oxley (SOX) control regulations within the supply chain function. Qualifications Experience Required : Essential: 7+ years of experience in supply chain management, particularly in the healthcare or pharmaceutical sectors. Proven track record in managing large, cross-functional teams and complex logistics operations. Desirable: Experience working in a highly regulated industry with an understanding of SOX compliance Qualifications Essential: MBA in Supply Chain Management or a related field. Desirable: Additional certifications in logistics or supply chain management (e.g., Six Sigma, APICS). Special Requirements: Travel: Yes, as required to manage operations and liaise with key stakeholders. Show more Show less

Job Description Key Responsibilities: Business Development & Sales Execution Achieve and exceed sales targets for assigned oncology products. Develop and implement territory business plans to maximize growth. Identify and engage key decision-makers in hospitals, cancer centers, and other healthcare institutions. Ensure effective product promotion and awareness among oncologists, medical professionals, and key stakeholders. Key Account & Stakeholder Management Develop and maintain strong relationships with oncologists, healthcare providers, hospital administrators, and procurement teams. Provide scientific and commercial support to HCPs to drive brand adoption. Understand customer needs and tailor solutions to enhance patient outcomes. Market Intelligence & Competitor Analysis Stay updated on market trends, competitor activities, and regulatory changes. Gather insights from the field and provide feedback to the marketing and medical teams. Identify gaps and opportunities to improve product positioning. Cross-Functional Collaboration Work closely with the medical, marketing, and regulatory teams to ensure compliance and effective brand positioning. Support marketing initiatives and medical education programs. Collaborate with internal teams to ensure smooth product access and supply chain management. Compliance & Reporting Ensure adherence to company policies, industry regulations, and ethical standards. Maintain accurate and up-to-date records of sales activities, customer interactions, and market insights. Provide regular reports on sales performance, challenges, and strategic recommendations. Qualifications Qualifications & Experience : Bachelor's degree in Pharmacy, Life Sciences, or a related field; MBA preferred. 2+ years of experience in pharmaceutical sales, with a focus on oncology. Strong understanding of oncology therapies, treatment protocols, and market dynamics. Proven track record of achieving sales targets and building key customer relationships. Excellent communication, negotiation, and presentation skills. Ability to work independently and adapt to a dynamic environment. Key Competencies: Business Acumen & Strategic Thinking Customer Relationship Management Market & Competitive Intelligence Strong Negotiation & Persuasion Skills Team Collaboration & Cross-Functional Coordination Ethical & Regulatory Compliance Awarenes Show more Show less

Key Responsibilities: Scientific & Medical Expertise Serve as a subject matter expert in neuroscience, providing high-quality scientific and medical support to internal and external stakeholders. Stay updated on the latest scientific advancements, treatment guidelines, and competitive landscape in neuroscience. Provide scientific training to internal teams, including commercial and market access teams. Stakeholder Engagement & Medical Communication Develop and maintain strong relationships with Key Opinion Leaders (KOLs), healthcare professionals (HCPs), and academic institutions. Lead scientific discussions and advisory boards to gather insights and address unmet medical needs. Deliver presentations at medical and scientific meetings, congresses, and symposia. Medical Strategy & Evidence Generation Contribute to the development and execution of the Medical Affairs Plan for neuroscience. Collaborate with cross-functional teams to provide medical input into brand strategies and regulatory submissions. Compliance & Ethical Standards Ensure all medical activities align with company policies, industry regulations, and ethical guidelines. Review promotional and non-promotional materials for scientific accuracy and compliance with regulatory standards. Key Requirements: Education: MD, BDS, PhD, or PharmD preferred (MSc or MBBS with relevant experience may be considered). Experience: Minimum 2 years of experience in Medical Affairs or a related role in the pharmaceutical industry, preferably in neuroscience. Scientific Knowledge: Strong understanding of neuroscience disease areas, treatment landscapes, and clinical data interpretation. Stakeholder Engagement: Experience in engaging with KOLs, HCPs, and scientific societies. Communication Skills: Excellent written and verbal communication skills, with the ability to translate complex scientific data into meaningful insights. Regulatory & Compliance Knowledge: Familiarity with local and global regulatory frameworks (e.g., ICH-GCP, FDA, EMA, DCGI guidelines).

Testing and release of Raw material, packing material and miscellaneous material samples. To maintain reserve sample as per SOP. Preparation of specifications of raw materials, packing material, in process and finished products and stability protocol as per requirement. Preparation of study protocols with respect to laboratory. Sampling of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Preparation of volumetric solutions, reagent solution, working standards and maintain records. To perform water analysis as per specification, SOP and GTP. To maintain daily water analysis trend record. To prepare and maintain Laboratory reagent and volumetric solution as per SOP. To keep neat and cleanliness at workplace and follow the good laboratory practices in the laboratory. Testing and release of in process, finished product, standards, and stability samples. To keep update of instruments logbooks and to record the data in Laboratory Notebook during testing. To perform the calibration, Maintenance of all instruments/equipment s as per respective schedule. To attain and complete self- training record. Preparation of indents as per the materials/product requirements. To prepare COA of various product/material as per requirement whenever required. Responsible to share the login credentials with new joiners. To ensure that employees in the department are trained as per the function mapping before work. To upload training copy of new/ revised SOP To ensure training and training related activities for the Department. To ensure the regular updating of Ad hoc/Classroom training details in training software. To generate re-training of any SOP for an employee/s as and when required Submit the employee training files to training cell in case any employee left or no longer with the organization. Responsible as a Department training coordinator (DTC) for the QCC Department Initiate AIMS Requisition for creation, modification, removal, addition, or employee inactivation in AIMS Software. Preparation and review of QC related SOPS. Preparation of general test procedures, method of analysis, specification as per requirement of raw material and packaging material. To initiate and review of A) Change controls B) Out of specifications C) Deviations

Description: The role involves ensuring CGMP compliance and supervising overall production activities of manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. Essential Functions: Responsible for preparation, review, revision, control, and implementation of standard operating procedures . Responsible for preparation & review of the master documents of production . Responsible for preparation and review of Protocols and reports based on the requirements. Responsible for Document management like BMRs, BPRs, Master SOPs etc.. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc.. Responsible for line clearance activity before commencing the operations like manufacturing, filling, capping & packing operations . To generate general purchase indent for departmental general items. Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials. Responsible to prepare daily production report as per the production achieved. Responsible to ensure that all equipment s and lines are in validated and calibrated status. Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same. Ensure the compliance & discipline . Responsible to makeshift schedule . Responsible to check that all the records and logbooks related to manufacturing, filling and sterilization of equipment s Additional Responsibilities: Responsible to give training to all the subordinates, technicians, and operators of the department. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Responsible to attend the training as per training schedule and to ensure training as per TNI.

Job Description: Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills

Responsible for commercial batch release to market. Responsible for in process Quality Assurance activities. Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components. Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for Sampling & compilation of Process Validation Reports (PVRs) Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Good Documentation recording and updation. Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs). Responsible for the routine GMP Inspection & review of Quality Records of other departments. Responsible for monitoring in Aseptic process simulation study. Responsible for Preparation and Compilation of Media Fill Protocol , Report. Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation. Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas Responsible for preparation and implementation of SOPs Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule. Responsible for personnel monitoring. Responsible to participate in qualification, requalification, area qualification activities. Activities other than in the Job responsibility are to be done as per requirement of HOD.

Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements. Qualification: B.Pharm/M.Pharm candidate with minimum 3-5 years experience in manufacturing QMS/Process review/Compliance.

Site survey and plotting of layout as per drawings. Interpretation of plans and specifications. Monitoring architectural, structural and finishing work execution as per drawings Monitoring work progress, quality, and compliance with building codes and regulations. Prepare and track schedules, ensure timely completion of project. Contractor management, bill checking as per tender BOQ. Co-ordination with seniors, contractors, and other professionals to meet the project outcomes. Preparing and sending daily progress report. Work with cross functional teams for timely completion. Monitoring Quality of works as per IS Inspects materials and judge work quality for conformance with contract Testing on site of materials as per ITP and QAP. Knowledge of safety practices, permits and norms. Knowledge of AutoCAD, civil estimation, MS Project/Primavera, and QA/QC protocols. Knowledge of cleanroom panels, cGMP practices, different type of finishes in pharma industry.

Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements. Qualification: B.Pharm/M.Pharm candidate with minimum 3-5 years experience in manufacturing QMS/Process review/Compliance.

Responsible for document management like BMR’s, BPR’s, master SOP’s etc. Responsible for preparation & review of the master documents of production. Responsible to ensure UAF working in area. Responsible for the handling of change control, deviations, investigation & CAPA, etc Responsible to give training to all the subordinates, technicians and operators of the department. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance. Responsible for line clearance activity before commencing the operations. Responsible to check that all the records and logbooks related to aseptic manufacturing, vial filling and vial sealing machine. Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department. Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area. Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area. Responsible for monitoring all the activities related to General, Control & Aseptic area. Responsible to ensure qualification and calibration status of equipment and instruments to avoid due/overdue. Responsible to ensure scheduled activity of respective area/equipment/instruments. Responsible to attend training as per schedule and to ensure training and work as per TNI. Follow the cGMP, Good Document Practice and discipline in the Company Premises. Qualification: M.Pharm./ B.Pharm./ M.Sc. Exp.: 3-7 years Candidate shall have experience in the Manufacturing of Injectable Products

Job Description Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.. Responsible to prepare protocols of process validation and cleaning verification/validation. Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..) Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system Qualifications M.sc / B.pharm / M.pharm Show more Show less

Job Description Site survey and plotting of layout as per drawings. Interpretation of plans and specifications. Monitoring architectural, structural and finishing work execution as per drawings Monitoring work progress, quality, and compliance with building codes and regulations. Prepare and track schedules, ensure timely completion of project. Contractor management, bill checking as per tender BOQ. Co-ordination with seniors, contractors, and other professionals to meet the project outcomes. Preparing and sending daily progress report. Work with cross functional teams for timely completion. Monitoring Quality of works as per IS Inspects materials and judge work quality for conformance with contract Testing on site of materials as per ITP and QAP. Knowledge of safety practices, permits and norms. Knowledge of AutoCAD, civil estimation, MS Project/Primavera, and QA/QC protocols. Knowledge of cleanroom panels, cGMP practices, different type of finishes in pharma industry. Show more Show less

Job Description Responsible for document handling, issuance, distribution, and retrieval of docume,verification of documents like Batch Manufacturing records, Batch Packaging Records, Protocols, layouts, specifications, Method of Analysis, Logbooks, Planner, etc. Responsible for issuance of approved Standard Formats and Logbooks to User Departments, Issuance of line-clearance checklist, interventions checklist and additional pages of BMR/ BPR as requested by user, reconciliation, retrieval and archival of issued standard formats and logbooks. To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA. Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.. Responsible to prepare protocols of process validation and cleaning verification/validation. Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..) Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system Qualifications B.Sc / M.Sc / B.Pharm / M.Pharm Show more Show less

Key Responsibilities JOB DESCRIPTION Scientific & Medical Expertise Serve as a subject matter expert in neuroscience, providing high-quality scientific and medical support to internal and external stakeholders. Stay updated on the latest scientific advancements, treatment guidelines, and competitive landscape in neuroscience. Provide scientific training to internal teams, including commercial and market access teams. Stakeholder Engagement & Medical Communication Develop and maintain strong relationships with Key Opinion Leaders (KOLs), healthcare professionals (HCPs), and academic institutions. Lead scientific discussions and advisory boards to gather insights and address unmet medical needs. Deliver presentations at medical and scientific meetings, congresses, and symposia. Medical Strategy & Evidence Generation Contribute to the development and execution of the Medical Affairs Plan for neuroscience. Collaborate with cross-functional teams to provide medical input into brand strategies and regulatory submissions. Compliance & Ethical Standards Ensure all medical activities align with company policies, industry regulations, and ethical guidelines. Review promotional and non-promotional materials for scientific accuracy and compliance with regulatory standards. Key Requirements Education: MD, BDS, PhD, or PharmD preferred (MSc or MBBS with relevant experience may be considered). Experience: Minimum 2 years of experience in Medical Affairs or a related role in the pharmaceutical industry, preferably in neuroscience. Scientific Knowledge: Strong understanding of neuroscience disease areas, treatment landscapes, and clinical data interpretation. Stakeholder Engagement: Experience in engaging with KOLs, HCPs, and scientific societies. Communication Skills: Excellent written and verbal communication skills, with the ability to translate complex scientific data into meaningful insights. Regulatory & Compliance Knowledge: Familiarity with local and global regulatory frameworks (e.g., ICH-GCP, FDA, EMA, DCGI guidelines). Qualifications Education: MD, BDS, PhD, or PharmD preferred (MSc or MBBS with relevant experience may be considered). Experience: Minimum 2 years of experience in Medical Affairs or a related role in the pharmaceutical industry, preferably in neuroscience. Show more Show less

To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products. Essential Functions: Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc). Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP). Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage. Performing qualification, periodic calibration, and maintenance of laboratory instruments. Maintain proper cleanliness, calibration, and qualification status of analytical instruments. Coordinate with warehouse and QA for sampling of incoming materials as per SOPs. Ensure proper labeling, storage, and disposal of samples and reference standards. Support internal, customer, and regulatory audits by providing required documentation and clarifications. Implement corrective and preventive actions (CAPA) as per audit observations. Additional Responsibilities: Participate in method validation, verification, and transfer activities as required. Assist in updating and reviewing SOPs, specifications, and analytical procedures. Contribute to continuous improvement initiatives in the QC department. Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor. Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.