Operate and clean packaging equipment as per SOPs. Maintain area and equipment per cGMP standards. Manage tooling and change parts for packaging equipment. Follow safety rules. Perform packaging tasks as instructed by supervisors. Handle materials as per approved procedures. Attend cGMP and SOP training from supervisors.

Responsible to follow the preventive maintenance schedule of machine. Responsible to check UAF working in area. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in area. Responsible to fill the logs, BMRs and documents of area as per SOP and work execution. Responsible to operate the machines and vessels of area as per SOP. Responsible for cleaning and sanitization of area as per SOP. Responsible for line clearance activity before commencing the operations as per SOP. Responsible for Manufacturing, Filling, Packing and Visual Inspection.

Proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at site by keeping track of quality metrics. Ensure all time readiness of site for regulatory/statutory inspections/ internal audits and Regularly monitor performance of each individual in Quality department. Facilitate internal and regulatory agency audits, and ensure findings from site audits are understood, assessed and addressed in a comprehensive manner . Ensure closure of audit observations by reviewing the CAPA and driving its implementation. Ensure implementation of requisite changes at the plant level as per global/local regulations. To escalate any Batch failure, Quality complaint, recall, critical observation etc. to senior management. Provide leadership and direction to ensure achievement of accountabilities for all Quality sub functions at site. Ensure timely updation and approval of all master documents i.e. BMR, SOPs, Specifications, site master file, validation master plan, schedules etc. To ensure that validation system remain updated as per regulatory requirements and industry standards. 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 of Standard Operating Procedures of Quality Assurance Department Responsible for preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System. Responsible for review of media fill BMR. To ensure timely release of manufactured batches by reviewing BMR/ BPR and their compliance. To ensure In- process testing & release timely. Training and post training evaluation of staff and worker: Identifying training needs, scheduling and conducting training program, training and qualification of trainer, certification and evaluation. 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 for review and approval of documents like Validation protocols, reports, QRM, SOPs etc. Responsible for the assessment, review and Approval of Change Control, Deviation, CAPA, Investigation etc. Responsible for approval of URS, DQ and vendor/ suppliers documents related to qualification. Annual Product Quality Review (APQR/APR) Review: Review & trending of quality parameter to quality performance consistency. Handling of Market Complaint: Complaint Investigation, root cause analysis, Impact assessment and risk assessment of received market complaint, FAR and Quality Defect reporting to Regulatory agency, trending of complaint and excellence study of complaint nature. Recall and Product Failure Investigation: Product failure investigation, Periodic inspection of retained, controlled and stability sample, handle the mock recall and product recall. To be part of investigation team & to perform the investigation of non-conformance (i.e. deviation, market complaint, OOS, OOT etc.). Trend analysis of deviations to evaluate recurring problem and to recommend the CAPA if required. Self-inspection of the different departments. Preparation and review of self-inspection report. To review the compliance/action plan against the noted observations noted during self-inspection. Co-ordination and participation in Quality management review. Approval of Master Documents like specification, Method of Analysis, Stability Study report, SOP etc. Vendor Qualification: Handling the Vendor Qualification and Re-approval audit for RM (Raw Material), PPM (Primary Packaging Material), SPM (Secondary Packaging Material), Contract analysis laboratory and Contract services.

Review of Change controls, CAPAs, Unplanned Deviations, Planned Deviations, Risk Assessment. Review of Out of Specification, Out of Alert limit, Computer system incident, Environmental Excursions. Performing investigation of Unplanned deviations, Out of specification, Out of Alert Limit, Computer system incident, Environmental Excursions. Tracking and closure of Change controls, CAPAs, Unplanned Deviations, Planned Deviations, Risk Assessment, Out of Specification, Out of Alert limit, Computer system incident, Environmental Excursions within allotted target date. Review and closure of effectiveness check of actions. Performing assessment of received other site CAPA and tracking closure. Evaluate CAPA and notifying to other sites. Preparation and review of SOPs. Preparation of presentation for QRB, Quarterly meeting. To perform the allotted task by HOD other than defined in Job Description.

Key Responsibilities: Packaging Development Innovation Lead the design, development, and validation of packaging components for existing and new pharmaceutical products. Drive packaging material selection, compatibility studies, and stability protocols in alignment with regulatory requirements (USFDA, EU, WHO, etc.). Implement sustainable, cost-effective, and innovative packaging solutions aligned with global trends. Project Team Leadership Manage a cross-functional team of packaging engineers and associates across development and commercial sites. Provide technical guidance and mentorship to the packaging team. Ensure timely execution of packaging projects, tech transfers, and commercialization activities. Regulatory Compliance Ensure packaging systems comply with cGMP, GDP, regulatory filings (ANDA, NDA, EU Dossier), and serialization norms (USDSCSA, EU-FMD). Support audits (regulatory and customer) by providing necessary documentation and technical justifications. Vendor Material Management Lead vendor development, qualification, and performance evaluation of packaging material suppliers. Collaborate with procurement and quality teams for material approval and cost optimization. Process Excellence Oversee packaging line trials, validation (PQ), and troubleshooting during manufacturing. Drive continuous improvement initiatives using Six Sigma, lean principles, and OEE enhancement. Technology Systems Evaluate and implement modern packaging technologies (Track Trace, tamper-evident packaging, QR coding). Work closely with serialization, automation, and IT teams to ensure integrated packaging solutions

Description: To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site Essential Functions: To be responsible for Analysis and Calibrations of Quality Control Laboratory instruments. To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware. To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions. To be responsible for Maintaining of Good Laboratory Practices in lab. To be responsible for Checking regular cleanliness of laboratory. To be responsible for Management of all types of Standards. To be responsible for Receiving and maintenance of Chromatographic columns. To be responsible for Cleaning of Instruments. To be responsible for Receiving samples and In-warding them in the respective registers/LIMS. To be responsible for Preparation and execution of Protocols. To be responsible for Maintain the contact with vendor. To be responsible for Daily temperature monitoring of QC laboratory Additional Responsibilities: To be responsible for Investigation related to LIR, deviations, OOS and OOT. To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPAs. To be responsible for Handling of Caliber e-LIMS Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HODs instruction and guidance.

Job responsibilities of mechanical engineer Plan, coordinate and execute mechanical engineering activities for projects (greenfield/brownfield) Review BOQs, layouts, specifications and ensure installation of HVAC, utilities and cleanroom systems as per cGMP FDA norms. Collaborate with cross-functional teams - QA, QC, Production, EHS, Maintenance - for seamless project execution and compliance. Monitor project schedules (MS Project), milestones and critical path to ensure on-time delivery. Lead vendor management, contractor supervision and technical review meetings for mechanical systems. Conduct equipment FAT/SAT, qualification protocols (DQ, IQ, OQ) and manage mechanical documentation for regulatory audits. Ensure adherence to safety, quality and statutory norms across all stages of mechanical work. Strong knowledge of HVAC systems, AHUs, Chillers, Compressors, Boilers, BMS, and cleanroom design. Familiar with IS, ASME, and cGMP engineering standards. Proficient in AutoCAD, MS Project/Primavera, and utility design tools. Knowledge of WFI, PW, steam and compressed air generation/distribution systems. Strong cross-functional coordination and leadership. High accountability and ownership of timelines. Detail-oriented, quality-driven, and safety-conscious. Excellent communication, negotiation, and documentation skills. Problem-solving mindset with agility to adapt to changes.

JOB RESPONSIBILITIES OF JUNIOR CIVIL ENGG 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 testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis Should have knowledge for the Method Verification/validation and Method Transfer analysis Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, stability and Finished product samples Should have awareness of Caliber LIMS system operation.

Create and manage Quality Control (QC) master data in the Laboratory Information Management System (LIMS), including product specifications, test methods, and sampling plans. Ensure the accuracy, completeness, and compliance of master data with regulatory requirements and internal SOPs. Perform self-review and coordinate for Level 2 review and approval. Collaborate with QC, QA, IT, and other relevant departments to gather required documents and inputs for master creation and updates. Manage master data changes in line with approved change controls, ensuring timely and compliant updates. Troubleshoot and resolve data-related issues in LIMS, coordinating with IT or vendors when required. Maintain up-to-date documentation of master data changes and support audits by providing necessary LIMS records. Ensure all activities adhere to GMP, regulatory guidelines (like USFDA, MHRA, WHO), and internal quality standards.

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity.

Coordinate and compile product data from various departments (Production, QC, QA, Warehouse, etc.) for APQR. Review manufacturing, testing, and deviation records to identify trends and areas for improvement. Ensure compliance with regulatory and company requirements for APQR documentation. Analyze critical quality attributes, in-process parameters, and batch performance. Identify corrective and preventive actions (CAPA) based on APQR findings. Prepare and finalize APQR reports within defined timelines. Support audits and regulatory inspections by presenting APQR documentation. Ensure timely closure of action items identified during the APQR process.

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity.