Pelltech Healthcare specializes in providing innovative digital health solutions to improve patient outcomes and streamline healthcare services.
Palghar
INR 5.0 - 5.0 Lacs P.A.
Work from Office
Full Time
JD DESCRIPTION- SAFETY OFFICER JOB DETAILS. Accountabilities & Responsibilities 1.Conduct safety Induction program for all new joinees 2.Continuous training programs for all employees working in the plant 3. Conduct Mock drills for emergency situations 4. Attend safety meetings in the plant and close safety points of such meetings 5. Communicate safety arrangements through Displays, Safety Signs, In House Magazines, Safety Literature, Annual Plant Safety Performance Report etc. 6. Participate in safety goal target setting, improvement project, Safety Suggestion Scheme, Safety Promotional activities etc. 7. Knowledge of Local Regulations related to MPCB, Factories Act, IBR, Fire system and EHS norms etc. 8. Knowledge of Safety Norms and Systems. 9. Knowledge of First Aid, Safety Measures / norms & System and PPEs. 10. Executing the Hazop study. 11. Conduct the EHS review against the Accident/ Incident and other case studies, unsafe condition and existing operation. 12. Preparation & review of aspect Impact Assessment & Hazard Identification & Risk Assessment templates & timely updating. 13. Knowledge of Fire System and Regulations. 14. Daily safety walk path in factory & factory premises. 15. Co - ordinate with engineering department for all types of permits, eg. Hot permit, height work permit etc. 16. Co - ordinate with HR & ADMIN department for periodical medical health check -up. 17. Preparation of documents required for all AUDITS. 18. SOP preparation & updation. 19. Yearly environment report. 20. Responsible for safety audit, risk analysis, on- site emergency plan. 21. To comply with factory inspector for factory inspection. 22. To control ETP plant with records of PH, COD, BOD. 23. To comply with MPCB for disposable of waste material generated from ETP. Requirement: Minimum 2-3 years of experience as Safety Officer Working in shifts Relocation to Plant location Qualification: ADISSM (Advance diploma in industrial safety and security management)
Palghar, Maharashtra, India
Not disclosed
On-site
Full Time
Job Responsibilities Monthly and Daily Calibrations of weighing balance and its records Updating of Cleaning Records and Packing Records Labelling of all equipment's in Packing Department Filling BPR Ensuring that packing material received from Stores as per BPR Monitoring yield losses during Packing process Oversee the production process and ensure that all products are packed and shipped in a timely manner Monitor the quality of the products and ensure that they meet the required standards Maintain accurate records of the production process Any other work allocated by Senior Ensure that all safety protocols are followed Troubleshoot any issues that arise during the production process Monitor inventory levels and order supplies as needed Coordination with other departments like QA, QC, Production, Stores etc. Pedigree 3-5 years of relevant experience in Packing Department in Pharmaceutical Manufacturing Company only Show more Show less
Palghar, Maharashtra, India
Not disclosed
On-site
Full Time
To ensure microbiological quality assurance and compliance of pharmaceutical products by overseeing and validating microbiology lab activities, documentation, and adherence to cGMP, regulatory guidelines, and company SOPs. Key Responsibilities Microbiological Testing & Daily Lab Operations Sampling and testing of: Raw materials (API & excipients) In-process materials Finished products Stability samples Routine testing: Total microbial count (bacteria/fungi) Pathogen detection (E. coli, Salmonella, P. aeruginosa, S. aureus) Water testing: Purified Water (PW), Water for Injection (WFI), and Potable Water Swab testing for equipment and personnel hygiene Environmental monitoring of manufacturing areas: Air sampling (viable and non-viable particles) Settle plate analysis Contact plate and swab testing on surfaces Compressed air and gas monitoring Documentation & Compliance (Lab-QA Functions) Preparation and review of: Standard Operating Procedures (SOPs) Specifications and test methods Analytical and microbiological reports Ensuring GDP (Good Documentation Practice) and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) Routine checks and approval of logbooks, analytical data, and lab records Involvement in data integrity audits and ensuring lab systems are 21 CFR Part 11 compliant (if applicable) Instrument Handling, Calibration & Qualification Operation, maintenance, and calibration of instruments like: Incubators, BOD incubators Laminar air flow units (LAF) Particle counters (non-viable monitoring) Autoclaves and hot air ovens pH meters, conductivity meters Ensuring timely calibration and preventive maintenance as per schedule Preparation of equipment qualification protocols and reports (IQ/OQ/PQ) Validations & Support to Production Participation in: Cleanroom validation (viable & non-viable monitoring) Disinfectant efficacy studies Media fill validation for process simulation (if sterile environment is involved) HVAC validation support Support in vendor qualification for microbiological consumables (media, reagents, disinfectants) Deviation, OOS, OOT & CAPA Handling Root cause analysis for any deviations, out-of-specification (OOS), or out-of-trend (OOT) microbiological results Initiation and follow-up of corrective and preventive actions (CAPA) Support in market complaint investigation related to microbiological quality Audits, Regulatory Compliance & Training Prepare for: Internal GMP audits External regulatory inspections (USFDA, MHRA, ANVISA, WHO, etc.) Customer audits Documentation support for Site Master File (SMF), Validation Master Plan (VMP), and Product Dossiers Educational Qualification B.Sc. in Microbiology / Biotechnology M.Sc. in Microbiology / Biotechnology Show more Show less
Palghar, Maharashtra, India
Not disclosed
On-site
Full Time
Job Responsibilities Responsible for handling all production activities pertaining to Pellets or Granulation. Responsible to handling all manufacturing activities as per Regulatory requirement. Responsible to handle the team to achieve the set targets & maintain qualitative & quantitative as well as cGMP aspects. Responsible for coordination with other departments . Process development in day to day activity for enhancement of optimization resulting, enhancement in productivity. Responsible to prepare daily, weekly & monthly reports & react accordingly to achieve the better targets. Monitoring all formulation activities. Online documentation i.e. BMR, LOG BOOKS & OTHERS. Supervise work force in department. Ensure all staff are conversant with production schedule. To ensure machines are within due date of preventive maintenance. Pedigree B.Pharm /M.Pharm with minimum 1-2 years of relevant work experience Show more Show less
Palghar, Maharashtra, India
Not disclosed
Remote
Full Time
To ensure that all vendors supplying materials (raw materials, packaging materials, outsourced manufacturing, and service providers) meet the company’s quality standards and regulatory requirements through a structured vendor qualification and evaluation process. Key Responsibilities Vendor Qualification Process: Initiate and coordinate vendor qualification activities for new and existing vendors. Prepare and maintain vendor qualification dossiers and files. Coordinate with procurement and other departments for vendor data and documentation. Ensure vendors comply with GMP, regulatory requirements, and company quality standards. Document Review: Review and evaluate vendor questionnaires, quality agreements, and technical documents. Assess vendor certifications (e.g., GMP, ISO), audit reports, and regulatory approvals. Verify supplier COAs and related test data. Vendor Audits: Plan, schedule, and conduct on-site and remote audits of vendors (with QA audit team). Prepare audit plans, checklists, and audit reports. Follow up on audit observations and ensure timely CAPA implementation. Risk Assessment: Perform risk assessments of vendors based on quality performance, audit results, and regulatory history. Categorize vendors as Approved, Conditional, or rejected based on risk rating. Performance Monitoring: Monitor ongoing vendor performance via complaint trends, deviations, OOS, and OOT data. Maintain vendor performance scorecards. Lead periodic review meetings to evaluate vendor quality performance. Quality Agreements: Draft, review, and manage quality agreements with vendors. Ensure roles and responsibilities related to quality are clearly defined. Change Control & Deviation Handling: Evaluate and manage vendor-related change control proposals. Handle deviations related to material supply and vendor performance. Show more Show less
Mumbai Metropolitan Region
Not disclosed
On-site
Full Time
We are seeking a highly motivated and detail-oriented individual to join our team as a Purchase Executive. The ideal candidate should have 1 to 5 years of experience in the Purchase department and possess excellent analytical and negotiation skills. As a Purchase Executive, you will be responsible for managing the procurement process, ensuring timely delivery of goods and services, and maintaining strong relationships with suppliers. Roles And Responsibilities Procurement of Packing Material (Foil, Cartons, Leaflet, PVC, Shippers) for Commercial & R&D. Coordinating with Stores to understand requirement. Arranging artworks from PMD & Sending Request for Quote to Vendors Creating PO. Following up with suppliers for status & on time delivery Inventory management through rescheduling dates Collecting Market Price trends for Material Coordinating with Stores for Store Queries Coordinating with Vendors for Vendor Questionnaire & Requalification Assessment Checklist & documents which is required to QA Handling Quantum Related Queries & Taking reports from Quantum (Material Landed Price Register/ Approved Vendor List/ Material wise Vendor List/ Unpassed etc.) Collect the Vendor form (SAP) & Documents from Vendor Approved shade cards to Vendor Coordinating with R&D for GRN of received material in R&D Ensuring set of bills of Payment processing, Scanning of Bills & PO for sending to Accounts Follow ups with Accounts Dept for Payment processing. Solving the wrong invoice’s Query (Wrong quantity or Rate & Wrong GST %) Pedigree Bachelor's degree in Business Administration, Supply Chain Management, or a related field. MBA in Pharmaceutical Management or Supply Chain (preferred) Proven experience as a Purchase Executive or in a similar role. Show more Show less
Palghar
INR 5.0 - 7.0 Lacs P.A.
Work from Office
Full Time
To ensure that all raw materials (API & excipients) are sampled, tested, and released. Key Responsibilities: 1. Sampling & Receipt 2. Testing & Analysis 3. Documentation & Release 4. Compliance & Audit Readiness 5. Instrument Handling Required Candidate profile Candidate must have experience in handling team of minimum 10 members. Candidate must have experience into routine analysis of raw material and QMS knowledge.
Mumbai Metropolitan Region
None Not disclosed
On-site
Full Time
The Senior Executive HR will play a pivotal role in overseeing payroll processing, recruitment efforts, and the development and administration of the organization’s rewards and recognition programs. This position is responsible for managing all aspects of payroll, ensuring accurate compensation for employees, driving the recruitment strategy, and fostering a culture of recognition and employee engagement. The role requires strong attention to detail, exceptional interpersonal skills, and the ability to drive HR initiatives that align with organizational goals. Key Responsibilities Payroll Processing: Manage the end-to-end payroll process, ensuring accurate and timely salary payments, including bonuses, allowances, and statutory deductions (e.g., PF, ESI, Gratuity). Ensure compliance with statutory requirements such as tax deductions at source (TDS), professional tax, and other applicable regulations. Handle payroll queries, address discrepancies, and provide necessary documentation to employees as required. Coordinate with the finance team to ensure accurate financial reporting and reconciliation of payroll data. Process payroll-related records, including salary advances, loans, and deductions, while maintaining confidentiality and data integrity. Ensure timely submission of statutory payments and filings related to payroll (e.g., PF, ESI, tax filings) Talent Acquisition & Recruitment Lead and manage the end-to-end recruitment process for various roles within the organization, ensuring timely and effective hiring. Collaborate with hiring managers to understand staffing requirements and recommend recruitment strategies. Ensure compliance with industry standards and labor laws during recruitment and onboarding. Manage relationships with recruitment agencies, headhunters, and job portals to attract top talent. Conduct interviews, assist with candidate selection, and negotiate job offers. Oversee the onboarding process for new hires, ensuring they receive proper orientation and integration into the company culture. Employee Relations Act as the first point of contact for employee concerns and provide guidance on HR policies, grievance handling, and conflict resolution. Develop and maintain strong employee relations by addressing workplace issues and ensuring a positive organizational culture. Promote an open-door policy and foster effective communication between employees and management. Ensure effective handling of employee grievances, facilitating resolution in a fair and transparent manner. Advise managers on employee engagement initiatives to improve morale, retention, and productivity. Performance Management Assist in implementing the performance management process, including setting goals, mid-year reviews, and appraisals. Provide support to managers in identifying skill gaps, performance issues, and career development opportunities for employees. Ensure that the performance evaluation process is aligned with business objectives and promotes a culture of high performance. Support managers in conducting feedback sessions and establishing individual development plans for employees. Compensation & Benefits Administration Assist in the administration of compensation structures and ensure alignment with industry standards and organizational policies. Manage and monitor employee benefits programs such as health insurance, retirement plans, and bonuses. Coordinate with external vendors to handle benefits processing and resolve any related issues. Oversee the monthly payroll process, ensuring accuracy, timely processing, and compliance with tax regulations. Provide support during annual compensation reviews and salary benchmarking. Compliance & HR Documentation Ensure the company complies with all Indian labor laws and statutory requirements, including the Industrial Disputes Act, PF, ESI, Gratuity, and other local and national regulations. Assist in maintaining proper documentation for employee contracts, performance evaluations, payroll records, and statutory filings. Keep track of compliance audits and ensure timely submissions of reports such as ESI, PF, and Income Tax filings. Conduct internal audits to ensure adherence to HR policies and compliance with regulations. Training & Development Support the identification of training needs across the organization and assist in the coordination and delivery of training programs. Partner with department heads to design and implement training initiatives that enhance employee skills and meet business requirements. Track and report on training program effectiveness and employee development metrics. Encourage a learning culture and ensure employees are aware of available training and development opportunities. Employee Engagement & Wellbeing Contribute to initiatives that promote employee engagement, wellness, and work-life balance, including employee recognition programs. Organize and support company events, activities, and celebrations that foster team spirit and promote a positive company culture. Assist in designing and implementing employee satisfaction surveys and use the results to suggest improvements in HR practices. HR Reporting & Data Management Maintain HR records and generate reports related to employee turnover, recruitment, compensation, and performance metrics. Prepare regular HR reports for senior management to track key HR performance indicators. Utilize HRIS systems to manage employee data and ensure its accuracy and confidentiality. Provide insights and recommendations based on HR data analysis to improve HR processes and organizational performance. Mandatory Requirement: Visit to Factory Location at least 2 times in a month Qualifications & Requirements Education: Bachelor’s degree in Human Resources, Business Administration, or a related field. A Master’s degree is a plus. Experience: At least 5 years of experience in HR, with a strong focus on payroll processing, recruitment, and rewards & recognition preferably within the pharmaceutical or healthcare industry. Strong exposure to Indian labor laws and compliance issues. Proven experience in recruitment, performance management, compensation & benefits, employee relations, and payroll processing. Exposure to HR systems (HRIS, payroll systems) and Microsoft Office Suite (Excel, Word, PowerPoint). Show more Show less
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
Job Responsibilities Quality Assurance Compilation of Supporting documents for Change Control/Deviation/CAPA/OOS. Responsible for Document Archival & up keeping. Preparation of Certificate of Analysis for Dispatch as per Sale order. To work & implement the cGMP practices in to all departments as per SOPs. Preparation of SOPs & relative documents. Document quality assurance activities with internal reporting and audit Develop new standards for production and design, with improvements as needed, and create testing protocols for implementation across all service lines Identify training needs and take action to ensure company-wide compliance Preparation of DMF/ QMS/ SOP/ Log books etc Inspect raw materials to ensure consistency and integrity Plan, Conduct and Manage Internal Audits and Customer Audits as per the plan in compliance with GLP, protocol, SOP's and applicable standard regulations Preparation of audit reports for the audits conducted and release the reports to concern HOD Preparation and review of SOP's, review of study protocol Access Suitability of responses to audit findings and negotiate suitable actions needed to resolve audit findings Review of deviations and find plans and follow-up and ensure for its implementation. Assist in preparation of the facility for client/sponsor audits and regulatory inspection Perform the reconciliation of Project and Non-project related documents and send or archival review the equipment calibration/validation records. Control of documents issuance, retrival, archival. Compiling of data for MIS as per schedule Allocation of batches as per customer purchase order over mail. Review of certificate of analysis for finished products. Skills Strong written and verbal communication skills Strong analytical and problem solving skills Good computer skills Self-motivated and able to prioritize the work. Pedigree B.Pharm/M.Pharm with 1-3 years of relevant work experience Show more Show less
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
Job Responsibilities Responsible for handling all primary and secondary packaging activities. Monthly and Daily Calibrations of weighing balance and its records Updating of Cleaning Records and Packing Records Labelling of all equipment's in Packing Department Checking of all packing activities as per BPR. Ensuring that packing material received from Stores as per BPR Monitoring yield losses during Packing process Coordination with other departments like QA, QC, Production, Stores, Engineering etc. Observation of Good Manufacturing Practices is laid down in packing department. Preparation of production planning (Plan vs Achievements, Maintaining Daily Reports). Handling of manpower & allocation of work at the start of shift / day. Sending requisition for BMR to QA & Dispensing to Warehouse Supervise the packaging activity to ensure maximum productivity. To ensure that proper cleaning, line clearance and operation of equipment during packing line setting. Indenting, issuance, and destruction of stereos and maintaining its record Pedigree 2-5 years of relevant experience in Packing Department in Pharmaceutical Manufacturing Company (Formulations -OSD Only) B.Pharm/M.Pharm/ M.Sc/B.Sc Show more Show less
Mumbai, Palghar
INR 4.0 - 7.0 Lacs P.A.
Work from Office
Full Time
Job Requirements: To calibrate pH meter, conductivity meter, Balance. Sampling & testing of Raw Material, Potable water, purified water by chemically as and when required. To check Temp & Humidity in microbial department. Expose plate in production area as well as microbiological section for environmental monitoring purpose. Daily documentation like log books, temp. & humidity records, cleaning records, sampling records, RDS, COA & various assigned registers entry in quantum system. To analyze RM, PM, & FG and preservative efficacy test micro biologically. To prepare media for MLT of RM, PM, & FG and preservative efficacy test as and when required. To maintain record of RM, PM, RAW WATER, POTABLE WATER & PURIFIED WATER & preservative efficacy test & finished products. To maintain instrument calibration schedule as well as calibration and its records. To checking of require media, chemicals & other relevant requirement for analysis and having requisition. In house validation of Autoclave, colony counter equipment and maintain records. Co-ordination within & other departments as and when required. As per work load ready to work overtime. Any other job as when assigned by the Senior Chemist & QC Manager. Pedigree: B.Sc/ M.Sc (Microbiology) with relevant 5-8 years of experience
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
To conduct and document analytical method validation (AMV), method verification, and method transfer activities for raw materials, in-process samples, and finished pharmaceutical products in compliance with ICH Q2(R1) , GMP , and regulatory standards . Key Responsibilities Analytical Method Validation Perform validation of analytical methods as per ICH Q2(R1) guidelines for: Assay and related substances (HPLC, UV) Dissolution, content uniformity, residual solvents (GC) Identification and other physicochemical parameters Conduct validation parameters: specificity, accuracy, precision, linearity, robustness, LOD/LOQ, system suitability, etc. Document results in validation protocols and summary reports. Method Verification Verify compendial methods (IP/BP/USP/Ph.Eur.) for RM/FP/IP samples. Confirm suitability of method for intended use before routine application. Prepare method verification reports and submit for review/approval. Method Transfer Participate in analytical method transfer (AMT) from R&D or third-party units. Execute comparative testing for transferred methods and compile transfer protocols. Coordinate with sending/receiving sites for method harmonization and troubleshooting. Instrument Handling Operate and troubleshoot instruments such as: HPLC (Empower, LabSolutions, Chromeleon) GC (Headspace, FID) UV-Visible Spectrophotometer FTIR, Dissolution Apparatus, TOC (if applicable) Documentation & Compliance Prepare and review: Validation protocols and reports Analytical worksheets and system suitability documents Adhere to GMP, GLP, and ALCOA+ principles. Maintain instrument logs, change controls, and CAPA logs where applicable. Audit Readiness & Regulatory Support Ensure all AMV data is audit-ready and compliant with regulatory expectations. Support in regulatory inspections (USFDA, MHRA, WHO-GMP, etc.). Address audit observations related to analytical validation. Instruments & Software Used HPLC, GC (Headspace, FID) UV-Vis Spectrophotometer, FTIR Dissolution Testers CDS Software: Empower / LabSolutions / Chromeleon Education :M.Sc. (Analytical / Organic Chemistry) / M.Pharm
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
Job Responsibilities Work in shifts and handling electrical and mechanical related breakdowns Jointly work with engineering team to attend major breakdowns Operating utility equipment's like air compressor, chiller plants, cooling towers, air handling units etc. Attend electrical and mechanical maintenance and fill up the record of respective equipment's Update daily readings of electrical and diesel consumption Report to Engineering Manager or his designee if any abnormalities noted in the utility equipments
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
REQUIREMENT: Exposure of Regulatory Audit minimum 04-05 times Independently (USFDA, TGA, EU, MHRA). Candidate Profile 12-20 yrs. exp. in engineering department (Formulation Plant Only). Good Knowledge and exp. in automated equipment required for Electrical, Maintenance & Utility. Should have a minimum of 8+ years of experience as an Engineering Manager, with independent management of an Engineering department, and substantial exposure to regulatory environments. Ability to effectively manage an engineering team. Must have handled USFDA, MHRA, and TGA & EU Regulatory Audit. Job Description Responsible for maintenance and utility management, project oversight, cost-saving initiatives, manpower management, regulatory compliance, and on-time execution of projects and shutdown plans. Day-to-Days-Responsibilities Monitoring and reviewing the operation and maintenance of equipments and facility catering to Process, HVAC and Utility equipment. Planning, Supervising and performing the planned preventive maintenance activity of Process, HVAC and Utility Equipment’s as per SOP and approved schedule. Monitoring and Supervising the HVAC operations for temperature and relative humidity continuously and for automated control system. Provide quality service system such as, potable water, Steam, compressed air, Vacuum etc. Maintain and monitor the HVAC and Utility system. Ensuring and updating document entries in daily logbooks of Utility Equipment’s, HVAC, Preventive maintenance Records, etc. Planning and Initiation of Capital Expenditure Request as per approved proposal related to facility, equipment’s, safety compliance and energy conservation. Tracking of CER for the timely approval from concerned stakeholders. Involvement in the planning of new facilities and equipment or their replacement. Providing the engineering support like modification / upgradation / changes required for the new product. Adhering the timelines for the completion as per target. Ensuring proper housekeeping and upkeep of Engineering areas (Service or Utility areas, Calibration/Validation Room, Technical areas, Hoist Machine rooms, Plant terrace, etc.) Identifying and implementing of various measures for controlling and reducing the available OPEX expenses by spare management and vendor development. Identifying new technologies and vendor development for the system improvement and ease of operation and maintenance. Ensuring the optimized inventory in engineering stores. Ensuring the availability of Critical spares required to avoid major production delay. Estimating the cost for maintenance, major modification and project activities. Planning and Co-ordinating with contractors and vendors for the scheduling of maintenance activities. Ensuring close supervision while execution of critical task for maintaining the quality and safety standards. Co-ordinating with concerned department in charges for timely execution of engineering activities. Tracking to be done for all the activities as per plan. Ensuring on-line bill processing against the availed services for the timely payment to vendor. Ensuring the statutory compliance related to process and utility equipment’s, HVAC and facility in coordination with EHS and other departments. Initiation of Purchase requisition for material and service procurement. Co-ordinating with purchase and vendor for clearing technical queries. Tracking of PR till the release of PO. Follow the cost approval flow before executing job. Ensure to attend the breakdown of machineries on time to have less impact on Quality and production and hand over. Inspection of material received at engineering stores and approving the same and maintains the required inventory level for all equipment spares and Consumables. Ensure timely executing Validation, Qualification and Calibrations protocols. Updating and reviewing status labelling of equipment’s, instruments and colour coding of Utility lines etc. Adhere to general overview of calibration. Follow-up with external vendors. Operational Excellence through implementation of Lean initiative such as 5S, Kaizen at shop floor. Gmp Review and update all engineering SOPs, Layouts and other related documents along with quality assurance. Following and execution of the appropriate HVAC and Utility validations, calibrations and qualification of all equipment are performed, recorded and reports are made available and suggesting changes for simplification of SOPs. Co-ordinating the temperature and relative humidity distribution study of store areas, manufacturing areas, cold storage etc. Co-ordinating the self-inspection and / or quality audit that regularly appraises the effectiveness and applicability of the Quality assurance system. Ensuring and maintaining the facility & equipment’s for all audit readiness. Monitoring and tracking of all the QMS tasks like, CR action, CAPA actions, and deviations for timely closure. Following and adhering to the current Good Manufacturing Practice (cGMP) practices for making continual improvement in Quality system. Following and adhering departmental standard operating procedures (SOP) & protocols and implementing the suggestions / ideas for simplification and improvements. Giving training to the team. Qms Operating software systems. Ensuring the timely reporting and acknowledgement of non-conformances. Ensuring the timely completion of investigation with root cause analysis and appropriate CAPA in place. Initiate the Change Request. Investigate and Initiate the deviation. Ehs Following work authorization permit system & execute the work. Making sure that personnel health, hygiene and organisation practices are followed. Preparing and implementing the risk analysis of non-routine maintenance activities, system, equipment and process. Monitoring safely operation of machine as per SOP with maximum efficiency Adhere to general electrical safety. Reviewing and updating the compliance of safety observations. Critical observations should be addressed immediately. Monitoring plant hygiene and adherence to Health safety and environment policy of the organisation. Performing the risk analysis, hazops of non-routine maintenance activities, system, equipment and process. Investigation of safety incidences with root cause analysis and appropriate CAPA in place to avoid the re-occurrence. Learning and sharing to be ensured among the concerned team. Training Identifying and conducting trainings to subordinates & Contractors for their development and improvement in skills and knowledge. Administrative: Identify areas of wastage. Co-ordinates with contractors and sub-contractors for scheduling of work. Supervision and Motivation of personnel EnMS Follow the energy management guidelines & systems and conduct energy Internal Audit, Action plan and compliance. Develop a program of energy-saving projects & measure, verify the savings achieved. Identifying and implementation of Energy Saving Measures at unit level. Adhering to Energy Management System (EnMS) SOPs and related documents. Others Performing any other assignment allocated. Planning and execution of plant shutdown activity.
Palghar
INR 2.0 - 4.0 Lacs P.A.
Work from Office
Full Time
Responsible for handling all activities pertaining to Tablets & Capsules & Pellets Mfg. Responsible to handle the team to achieve the set targets & maintain qualitative & quantitative as well as cGMP aspects. Perks and benefits Accommodation & Transportation And Mediclaim
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
Job Responsibilities Arranging of Raw Material & Packing Material for dispensing Dispensing Raw Material & Packing Material against authorized Batch Manufacturing Record (BMR) & BPR and blend sheet to Production & Packing Department Filling BMR, BPR, Log book and other relevant documents Updating all GMP records on daily basis Checking and verification of all Return Material To look after finished goods & dispatched goods. Aware about requirements of GST,E-way bill, pharma bill. Co-ordination with transporters, GMP documentation process. End to end process form Inward of material to Dispatch with documentation. Ensuring safety at dispensing booth Any other work allocated by the Department Head Pedigree B.Com/ M.Com
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
Job Responsibilities Conduct in-process quality checks at various stages of manufacturing, including sampling, inspections, and testing, to ensure compliance with SOPs and regulatory requirements. Review and compile complete batch records (BMR and BPR) prior to release. Monitor steps followed in manufacturing and packing are as per standard operating procedure. Ensure all instruments are calibrated and validations are carried out in timely manner. Issue Validation Protocol, Method Validation Protocol, URS & Qualification as per the schedule. Monitor critical process parameters, such as temperature, pressure, pH, and mixing times, to ensure they are within specified ranges. Review and approve batch records, manufacturing instructions, and other relevant documents to verify compliance with established procedures and specifications. Perform line clearance activities to ensure proper segregation and cleanliness of manufacturing areas, equipment, and materials. Collect and analyze samples during production runs for physical, chemical, and microbiological testing as per defined sampling plans. Withdraw stability sample & control samples for analysis at intermediate and finished product stage. Issue, Review & Maintain Change Control of Site, Corporate & their respective logs. Issue controlled copies and retrieval of old RMS, FPS, SPS, PMS, RM & PM Item Code List. Coordinate with the quality control (QC) department for timely testing and release of in-process samples. Investigate and document deviations, non-conformances, and out-of-specification results, and collaborate with the appropriate teams to identify root causes and implement corrective actions. Assist in the implementation and maintenance of quality systems, including change control, risk assessment, and document control. Support internal and external audits by providing necessary documentation and participating in audit activities. Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to resolve quality-related issues and drive continuous improvement initiatives. Maintain accurate and up-to-date records of all IPQA activities and documentation, ensuring compliance with GMP (Good Manufacturing Practices) and other regulatory guidelines. Identify and report the non-compliances observed in individual departments. Issue controlled copies & retrieval of old SOPs and QAPs. Handling of Deviations & CAPA. Handling / investigation of product complaints, incident reports, batch failures and product recalls. Preparation, Updation, issuance, retrieval of Price list. Document submission as per Regulatory requirement. Any other assignments allocated by Unit QA from time to time responsibilities Stay informed about current industry practices, regulatory requirements, and quality trends to enhance IPQA processes. Pedigree B.Pharm/ M.Pharm with minimum 1-3 Years of experience in IPQA
Palghar, Maharashtra, India
None Not disclosed
On-site
Full Time
Job Summary We are seeking a dynamic and detail-oriented professional to join our R&D/F&D team focused on Oral Solid Dosage (OSD) forms, including pellets and tablets. The ideal candidate will be responsible for conducting pre-formulation and formulation development studies, process validation, stability studies, and technology transfer of new pharmaceutical products, while ensuring adherence to ICH guidelines and internal SOPs. Key Responsibilities Literature Survey & Research: Conduct detailed literature reviews to support new product development initiatives. Evaluate reference products, patents, regulatory status, and formulation strategies. Pre-Formulation Studies: Perform physicochemical characterization of API and excipients. Assess compatibility, solubility, and stability as part of pre-formulation studies. Formulation Development: Design and develop robust formulations for tablets and pellets. Optimize process parameters through laboratory and pilot-scale trials. Stability Studies: Conduct stability studies as per ICH guidelines and internal SOPs. Interpret results and recommend necessary formulation or process adjustments. Process Validation: Coordinate and execute process validation batches in the production department. Ensure compliance with GMP and validation protocols. Technology Transfer: Prepare and review complete technology transfer documentation (TTD). Facilitate successful scale-up and handover of developed products to manufacturing. Troubleshooting: Provide technical support for commercialized products to resolve formulation or process issues. Documentation & Record-Keeping: Prepare and update Product Development Files (PDF), Product Logbooks, and Instrument Logbooks regularly. Draft and review documents such as QAQN (Quality Assessment & Qualification Note), MFR (Master Formula Record), and FPS (Finished Product Specification). Qualifications Education: B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology. Experience: 1–3 years of relevant experience in F&D/R&D, preferably in OSD (tablets/pellets) formulation development in a regulated environment.
Mumbai Metropolitan Region
None Not disclosed
On-site
Full Time
The role involves supporting the end-to-end coordination of pharmaceutical development projects, ensuring regulatory alignment, smooth interdepartmental collaboration, and timely achievement of project milestones. Job Responsibilities Assist in overseeing the complete product development cycle—from R&D initiation to process validation and readiness of dossier, ensuring timeline adherence and departmental coordination. Support in identifying, evaluating, and finalizing API vendors based on some factors. Ensure timely procurement and delivery of R&D essentials including APIs, excipients, and reference listed drugs (RLDs). Facilitate the procurement of RLDs for both R&D and bioequivalence (BE) studies. Coordinate with internal teams (R&D, QA/QC, RA, Supply Chain, and Production) to address ongoing requirements. Coordinate with patent consultants for literature and IP reviews, and with CROs for BE application documents. Monitor and track procurement schedules for materials required in process validation batches. Maintain clear project documentation, and support tracking of action items. Requirements Education: Bachelor’s degree in Pharmacy (B. Pharm) Experience: Freshers are welcome. Prior internship or training in product development or project coordinator is a plus. Skills: Strong communication and interpersonal skills. Basic understanding of pharmaceutical products (OSD segment preferred). Proficiency in MS Office (Excel, PowerPoint, Word). Ability to learn quickly and adapt to new environments
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