328 Jobs in Palghar - Page 8

Role & responsibilities A Quality Assurance Manager (QAM) ensures products meet quality standards by planning, coordinating, and implementing quality assurance programs, focusing on efficiency, waste reduction, and profitability . Quality System Implementation: Develop and implement quality assurance programs and policies. Establish quality procedures, standards, and specifications. Ensure compliance with international and national standards. Develop and maintain quality documentation, including inspection criteria, SOPs, and quality manuals. Quality Control and Inspection: Monitor and inspect garments and fabrics at different production stages (e.g., cutting, sewing, finishing). Ensure garments meet company and industry quality standards. Identify and address quality issues and defects. Supplier Management: Work with purchasing staff to establish quality requirements from external suppliers. Evaluate and monitor the performance of suppliers. Process Improvement: Identify areas for improvement in production processes. Implement corrective actions to address quality issues. Promote continuous improvement in quality processes. Data Analysis and Reporting: Collect, analyze, and interpret data related to quality performance. Prepare reports and presentations on quality issues and trends. Team Management: Supervise and train quality control staff. Motivate and inspire the team to achieve quality goals. Customer Focus: Review customer feedback and understand customer demands and expectations. Ensure that products meet customer requirements. Preferred candidate profile Denim bottom manufacturing experience required

As a member of a multi-disciplinary team, you will utilize your creativity and range of engineering skills to develop customized solutions. You will be involved in the design and manufacturing of new solutions. It is an opportunity to take ownership of your design all the way from concept to final manufacturing. There will be collaboration with both customers and vendors to develop top notch solutions for a number of challenging problems. Use 3D CAD software to create models and drawings of machinery Develop customized solutions after interfacing with customers Oversee project management along with technicians Develop prototypes as per the requirements of the marketing team Perform testing on engineering prototypes Confirm system capabilities by designing feasibility and testing methods Organize and maintain existing engineering records Document fabrication, assembly and installation processes

As a member of a multi-disciplinary team, you will utilize your creativity and range of engineering skills to develop customized solutions. You will be involved in the design and manufacturing of new solutions. It is an opportunity to take ownership of your design all the way from concept to final manufacturing. There will be collaboration with both customers and vendors to develop top notch solutions for a number of challenging problems. Use 3D CAD software to create models and drawings of machinery Develop customized solutions after interfacing with customers Oversee project management along with technicians Develop prototypes as per the requirements of the marketing team Perform testing on engineering prototypes Confirm system capabilities by designing feasibility and testing methods Organize and maintain existing engineering records Document fabrication, assembly and installation processes

Talent Acquisition & Workforce Management Compliance & Statutory Requirements Employee Relations & Welfare Training & Development Performance Management & Retention HR Operations & Payroll Industrial Relations & Contract Labour

Role & responsibilities Responsibility: Handling multiple buyer enquiries from order receipt to payment receipt. Creating production files (Style Sheets, Tech Packs, Spec Sheets, Measurement charts, Patterns, Standard samples, Artworks, Raw Material (RM) BOM, RM & Trim cards, Comment sheets etc.). Pre, post and inline approvals of RM, trims, and production samples. Production coordination with departments. Monitoring production planning and execution to achieve timely deliveries. Updating buyer/management on delivery status. Making & reporting MIS data. Travel for meetings to buyer or supplier offices locally or out station (National). Preferred candidate profile 5+ years in denim merchandising

Hiring Quality Control Executive/ Chemist for API Industry. Should be very much intrested in QC Role and who wants to do the career in QC. This opening is for freshers only. Required Candidate profile Should be Bsc or msc in chemistry. Should be nearby Boisar,Dahanu,Palghar or Tarapur location. sound knowldge of HPLC and GS instruments.

Job Description As a member of an evolving organization, you will have the opportunity communicate with a clientele spanning 16 industrial sectors. This is a creative and communication-oriented role. Owing to the diversity of clients we cater to you will gain excellent experience in multiple sectors. Communicate with potential customers to understand their requirements and provide a suitable offer Handle enquiries received from the marketing team and other channels Support market research activities Arrange the effective distribution of marketing materials Maintain and update customer databases All other sales activities, and must be well organized Support content generation activities for marketing Primarily office-based job

Handle day to day administrative activities Handle petty cash expenses Support recruitment activities Handle paperwork for employees Support any documentation activities for orders or miscellaneous work Handle paperwork for order dispatches and material receipts in the factory Handle purchase follow ups Maintain and update customer databases Primarily office-based job 0-2 Yrs of Experience required

Job Responsibilities Literature survey of new products. Pre-formulation studies of new products. Formulation development of new product of Pellets/Tablets. Stability studies as per SOP ICH Guidelines for developed products. To take process validation batches of pellets and tablets in production department. Technology transfer of developed products. Trouble shooting of commercialized product as and when required. Follow-up of sampling sheet sent by sales department. Collection of samples for Export Registration and sent to RA Department. Co-ordinate with other department for other queries or vice versa as and when required. Preparation and update of product file, product log book Instruments log book regularly. Preparation of document for technology transfer like, QAQN, MFR, FPS. Pedigree 1-3 years of relevant work experience in RD Formulation Development Department B.Pharm / M.Pharm

Job Responsibilities : Analysis of Vendor Approval samples. Preparation and Standardization of Solution, as and when required. Implementation of GLP / GMP requirements. Analysis of Raw Materials / Finished Products / Stability samples/Packing materials. Samples and related documentation as per cGMP requirement. Ensure analysis of Raw Materials / Finished Products / Stability Samples as per requirement from outside commercial lab. Review of laboratory chemicals. Calibration of instruments like HPLC, UV, IR, Dissolution, KF Potentiometer etc. as and when required. Performing Working standard qualification Preparation and Standardization of Solution, as and when required. Maintenance of Stability Incubators. .Loading removal of samples from Incubators its documentation. Review of Analytical data, calibration data, qualification data etc. Requirement: Minimum 1-3 years of experience in Quality Control Department Working in shifts Relocation to Plant location Qualification: B.Sc/ M.Sc/ B.Pharm

Job Responsibilities : Analysis of Vendor Approval samples. Preparation and Standardization of Solution, as and when required. Implementation of GLP / GMP requirements. Analysis of Raw Materials / Finished Products / Stability samples/Packing materials. Samples and related documentation as per cGMP requirement. .Ensure analysis of Raw Materials / Finished Products / Stability Samples as per requirement from outside commercial lab. Review of laboratory chemicals. Calibration of instruments like HPLC, UV, IR, Dissolution, KF Potentiometer etc. as and when required. Performing Working standard qualification Preparation and Standardization of Solution, as and when required. Maintenance of Stability Incubators. .Loading removal of samples from Incubators its documentation. Review of Analytical data, calibration data, qualification data etc. Requirement: Minimum 5-8 years of experience in Quality Control Department Working in shifts Relocation to Plant location Qualification: B.Sc/ M.Sc/ B.Pharm

Human Resources (HR): Recruitment and Staffing: Managing the recruitment process for plant personnel (operators, technicians, administrative staff, etc.). Sourcing candidates, conducting interviews, and onboarding employees. Ensuring compliance with labor laws and regulations in Maharashtra. Employee Welfare and Relations: Act as a liaison between employees and management to resolve any workplace issues or grievances. Organize welfare programs and employee engagement activities to boost morale and productivity. Ensure the adherence to health and safety standards and contribute to a safe working environment. Training and Development: Organizing training programs on GMP (Good Manufacturing Practices), safety protocols, and other essential skills. Identifying skill gaps and developing a continuous learning culture. Payroll and Benefits Administration: Preparing monthly payroll data for permanent and contract employees Managing employee benefits such as insurance, medical, and retirement plans. Ensuring statutory compliance with Provident Fund (PF), Employee State Insurance (ESI), and other legal requirements. Performance Management: Implementing performance appraisal systems and handling performance-related issues. Assisting in talent development and succession planning for critical roles. Administration: General Administration: Overseeing day-to-day administrative functions including office supplies, record-keeping, and inventory management. Managing transportation, company accommodation, and other logistics for employees, especially since the plant is in a remote area. Coordinating with external vendors for services like security, cleaning, and maintenance. Annual Medical Health Check-up as per GMP guidelines Compliance and Documentation: Ensuring compliance with local labor laws, factory regulations, and other legal requirements relevant to pharmaceutical manufacturing. Maintaining and updating all plant-related administrative records (employee records, attendance logs, leave records, etc.). Facility Management: Supervising facility upkeep, ensuring cleanliness, security, and overall maintenance of the plant. Handling plant security arrangements, including physical security staff and monitoring systems. Health and Safety Management: Ensuring adherence to occupational health and safety regulations. Conducting safety drills and implementing emergency preparedness programs. Communication and Coordination: Liaising between management and employees to ensure smooth communication and address any concerns promptly. Coordinating with different departments (e.g., production, quality control, and supply chain) to ensure administrative support is provided as needed. Logistical Support: Managing the transportation of materials, goods, and staff, especially important in remote locations with logistical challenges. Arranging for local travel or accommodation for employees coming from distant areas. Other Duties: Handling leave and attendance management of permanent and contract employees Attending court cases as a company representative Managing plant security, guest relations, and ensuring adherence to company policies. Coordinating employee events or celebrations, if applicable. Working on cost-control initiatives and optimizing operational expenses related to HR and administration. Qualifications: Educational Qualifications: Bachelor s or Master s degree in Human Resources , Business Administration , or related fields. A specialized course or certification in Labor Law , Industrial Relations , or Pharma Management can be an advantage. Experience: Typically, 3-8 years of experience in HR Admin functions, with at least 2-3 years in the pharmaceutical industry or manufacturing sector. Prior experience in an OSD pharma plant or a regulated environment (such as EU Plant) would be a significant advantage.

Should be able to manage the store activities from receipt to dispensing of RM/PM with enforcing GMP at all times. All time audit preparedness, responsible for accountability of manpower utilization, departmental discipline, maximum utilization of available resources. To follow Good Documentation practices and safety instructions ensure compliance while working in warehouse. Receiving of Raw materials and Packing materials and Prepare Goods receipt Note (GRN) Recording of Temperature, Relative Humidity and Differential Pressure in stores and Finished Goods area. Arrangements of Raw material and Packing material in stores according to the status i.e Under test Approved, Rejected and Quarantine etc. Dispensing and issue of Raw materials and Packing materials to production and Packing department as per respective Batch manufacturing and Packing record Filling the Equipment Logbooks and area logbooks and entries in Batch manufacturing and Packing record after dispensing. To perform the Calibration and Verification of Weighing balances. Ensure compliance with current Good manufacturing Practice (cGMP) in warehouse. Manpower handling in warehouse department. Physical verification of stocks as per Standard Operating procedure. Follow up with Quality control department for timely sampling and release of materials. Preparation of Standard Operating Procedure related to warehouse department. To provide SOP Training to juniors or new joining persons. Responsible for Handling of Change control and Deviations. Prepare packing list and dispatch plan for Finished Goods and dispatch of Finished Goods. Identify the materials which are due for Retesting on monthly basis and inform to respective department for sampling of the same. Handling of Damaged, Rejected and Expired materials in warehouse. To follow online documentation in Raw material, Packing material and Finished Goods store. Follow up with purchase and commercial department for disposal of non moving, obsolete and rejected raw and packing materials Temperature mapping in Stores and Finished Goods area. Posting and Transaction of materials in SAP. Pedigree B.Sc with atleast 5 years of relevant experience in Stores Department

To lead IPQA (In process Quality Assurance) Team and its monitoring by assigning tasks for IPQA chemists in day to day activities. Participating, reviewing and approval of protocol and reports of user requirement specifications, qualifications, validations, risk assessment and any other study to be performed at the site. To ensure the commitments (marketing authorization and the manufacturing authorization requirements) given to regulatory authorities for the products have been met for the batch concerned. To participate in designing, developing, approving and implementation of the quality systems at the manufacturing site. Participate in the external inspections of the manufacturing site, prepare Corrective and Preventive Action (CAPA) plan for observations and monitor its implementation. Review of Out-Of-Specification (OOS) and Out Of Trend (OOT) investigation reports. Participate in the investigation of complaint, deviation, change control, non conformance, incidence, returned goods, product recall, vendor audit, external testing laboratories audit; its impact assessments; review its reports and monitor the implementation of Corrective and Preventive Action (CAPA). Participate in self inspection and implementation of its observations. Review of training manual and provide training on cGMP and quality systems Overview of Product Quality Review (PQR) and approval of its reports. To oversee that quality systems, procedures, validation master plan, site master file, quality manual and such documents are maintained in current state and implemented effectively. Preparation of Monthly MIS report including IPQA activities for QA Department. To look for continuous improvement. To approve documents in the QUANTUM software after approval of Head QA or Designee . To oversee the fulfillment of regulatory requirements of RA department. Releasing or rejecting all finished products in absence or direction of Manager QA. Responsible for Ensure the control sample and stability samples of finished product and submission to the QC for analysis Review of Standard Operating Procedures (SOPs) and guidance to the junior in preparation of SOPs. Perform vendor audit for starting material and packaging material vendors; external testing laboratories and other service providers. Coordination with formulation and development department for new product introduction at facility or change in product process or formula. To oversee analytical method validation and verification activity. The additional responsibilities shall be delegated on day to day basis under authorization of Manager-QA. Pedigree B.Pharm/ M.Pharm with minimum 12 years of relevant experience in IPQA department

We are seeking an experienced Head in the Quality Assurance department to oversee and ensure the highest level of quality standards across our organization. The ideal candidate will have at least 15 years of experience in quality assurance, with a proven track record of managing and leading a team. 1. Quality Management System (QMS) Oversight Develop, implement, and maintain the Quality Management System in compliance with local and international regulations (e.g., CDSCO, WHO, USFDA, MHRA). Conduct regular reviews and updates of QA policies and procedures. 2. Regulatory Compliance Ensure all manufacturing processes and documentation comply with regulatory requirements. Prepare for and manage regulatory inspections and audits. Liaise with regulatory bodies and ensure timely submission of required documentation. 3. Product Quality Assurance Oversee all aspects of quality control for OSD formulations, including raw materials, in-process controls, and finished products. Approve or reject raw materials, intermediates, and finished products based on quality standards. 4. Quality Control (QC) Coordination Collaborate closely with the QC department to ensure proper testing of materials and products. Review and approve QC reports and ensure timely release of products. 5. Deviations and Investigations Lead investigations into quality incidents, deviations, or non-conformances. Implement corrective and preventive actions (CAPA) to prevent recurrence. 6. Documentation and Record Keeping Ensure proper documentation practices (GDP) are followed. Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other critical documents. 7. Training and Development Conduct training programs for QA and plant staff on quality standards, regulations, and best practices. Foster a culture of continuous improvement and compliance. 8. Supplier and Vendor Management Approve and audit suppliers and vendors to ensure the quality of raw materials and services. Ensure supplier compliance with quality agreements and standards. 9. Risk Management Identify, assess, and mitigate risks associated with product quality. Conduct risk assessments and implement control measures as necessary. 10. Cross-functional Collaboration Work closely with production, RD, and other departments to ensure quality is integrated into all processes. Provide QA support during product development and technology transfer. 11. Continuous Improvement Drive continuous improvement initiatives to enhance product quality and operational efficiency. Monitor industry trends and update practices accordingly. 12. Ethical and Safety Compliance Ensure all QA activities are conducted ethically and with a focus on employee and consumer safety. Promote a safe working environment and adherence to health and safety regulations. This role demands strong leadership, excellent communication skills, and a deep understanding of pharmaceutical quality standards and regulatory requirements Preferred candidate profile Head- Quality Assurance in EU approved OSD Pharma Plant Perks and benefits Company Family Accommodation will be provided Personal Mediclaim and Accident Insurance upto Rs 5 lakhs

Job Responsibilities: Preparation and review of SOP, Validation procedures, General testing procedures, Protocols, Summary reports, Trends, Investigation reports, Risk assessments, Rationale, Quality policies, Audit responses, Justification notes, CAPAs and related documentation. To ensure availability and implementation of approved specifications, sampling instruments and test methods Check and review analysis of packing material, raw material, in process and finished goods Preparation of raw data sheets for raw material, packing material, in process and finished goods Preparation, execution and review of validation protocols and equipment qualification protocols. Verification and approval of laboratory analytical reports of MLT, Water, Environmental Monitoring, Bioburden of In-process Materials, Bioburden analysis as per current specification and SOPs. Review and Monitoring of all types of routine non routine activities like calibration, validation, Media Preparation, Culture handling, water analysis etc. Review of daily documents like usage log books of instruments, temperature differential pressure humidity records, cleaning records, sampling records, RDS, COA and various assigned registers entry To carry out analysis of In-process, raw material, packing material and finished goods and Preservative efficacy test micro biologically. To ensure the compliance of laboratory system, GLP and cGMP To ensure Environmental Conditions Pharmaceutical Water qualities are maintained in respectively by preparing and reviewing the Trends of Environment Monitoring Water Risk assessments and Rationale for MLT, Water, BCC and Environment Monitoring. Sampling microbial analysis of raw water, portable water, purified water as and when required Sampling frequency reducing and Structural problem solving. Co-ordinate within and other departments as and when required Work distribution and allocation amongst subordinates as per the requirements Pedigree: B.Sc/ M.Sc (Microbiology) with relevant 8-12 years of experience

: 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 1-3 years of experience

To lead IPQA (In process Quality Assurance) Team and its monitoring by assigning tasks for IPQA chemists in day to day activities. Participating, reviewing and approval of protocol and reports of user requirement specifications, qualifications, validations, risk assessment and any other study to be performed at the site. To ensure the commitments (marketing authorization and the manufacturing authorization requirements) given to regulatory authorities for the products have been met for the batch concerned. To participate in designing, developing, approving and implementation of the quality systems at the manufacturing site. Participate in the external inspections of the manufacturing site, prepare Corrective and Preventive Action (CAPA) plan for observations and monitor its implementation. Review of Out-Of-Specification (OOS) and Out Of Trend (OOT) investigation reports. Participate in the investigation of complaint, deviation, change control, non conformance, incidence, returned goods, product recall, vendor audit, external testing laboratories audit; its impact assessments; review its reports and monitor the implementation of Corrective and Preventive Action (CAPA). Participate in self inspection and implementation of its observations. Review of training manual and provide training on cGMP and quality systems Overview of Product Quality Review (PQR) and approval of its reports. To oversee that quality systems, procedures, validation master plan, site master file, quality manual and such documents are maintained in current state and implemented effectively. Preparation of Monthly MIS report including IPQA activities for QA Department. To look for continuous improvement. To approve documents in the QUANTUM software after approval of Head QA or Designee . To oversee the fulfillment of regulatory requirements of RA department. Releasing or rejecting all finished products in absence or direction of Manager QA. Responsible for Ensure the control sample and stability samples of finished product and submission to the QC for analysis Review of Standard Operating Procedures (SOPs) and guidance to the junior in preparation of SOPs. Perform vendor audit for starting material and packaging material vendors; external testing laboratories and other service providers. Coordination with formulation and development department for new product introduction at facility or change in product process or formula. To oversee analytical method validation and verification activity. The additional responsibilities shall be delegated on day to day basis under authorization of Manager-QA. Pedigree B.Pharm/ M.Pharm with minimum 5-8 years of relevant experience in IPQA department

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

Job Responsibilities Responsible for handling all production activities pertaining to Tablets Capsules. 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 formulations 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 1-3 years of relevant work experience

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 3-5 years of experience

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, SOPs and applicable standard regulations Preparation of audit reports for the audits conducted and release the reports to concern HOD Preparation and review of SOPs, 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

Roles and Responsibilities Engineering Spares and Consumables: Manage inventory of spares like machine parts, belts, bearings, motors, filters, and lubricants used in equipment maintenance. Ensure availability of consumables such as nuts, bolts, welding rods, and electrical items. Coordinate with the maintenance department for preventive maintenance schedules. Maintain critical stock levels to avoid production downtime. Safety and Utility Materials: Handle inventory of safety equipment such as PPE kits, gloves, masks, fire extinguishers, and first aid materials. Manage cleaning agents, solvents, disinfectants, and other utility items. Ensure proper storage and compliance with safety standards for hazardous items. Laboratory Materials: Oversee inventory of laboratory chemicals, glassware, and consumables like filters and pipettes. Coordinate with the Quality Control (QC) team for timely replenishment. Ensure proper labeling and segregation to prevent contamination or misuse. Change Parts and Machine Accessories: Store and manage change parts for equipment like tablet presses, blister packing machines, and encapsulators. Maintain records of usage and ensure readiness for product changeovers. IT and Office Supplies: Manage IT equipment like printers, cables, routers, and office consumables such as stationery, toners, and general supplies. Ensure smooth functioning of IT-related inventory. Scrap and Disposal Management: Oversee proper storage and segregation of scrap materials (e.g., rejected engineering parts, obsolete equipment). Coordinate with approved vendors for safe disposal as per regulatory guidelines. Calibration and Special Equipment: Track calibration equipment and devices for periodic testing and verification. Maintain logs and coordinate with QC or engineering teams for timely recalibration. Skills and Knowledge Required: Technical Expertise: Basic understanding of engineering components and safety materials. Familiarity with laboratory equipment and consumables. ERP and Inventory Management: Proficiency in systems like SAP, Oracle, or similar for inventory tracking. Compliance Knowledge: Awareness of GMP, EHS (Environment, Health, and Safety), and GDP standards. Coordination Abilities: Liaise effectively with maintenance, QC, IT, and admin teams. Qualifications: Educational Background: Diploma/Degree in Engineering, Pharmacy, or Supply Chain Management. Experience: 1-3 years in inventory or warehouse management, preferably in a pharmaceutical or manufacturing setup.

Perform analytical method development, method validation and query response for the finished product. Prepare analytical method development reports, CDP and COA (Certificate of Analysis) Perform and review analysis of In-process sample/Finished goods/ Stability samples and related documentation as per cGMP requirement. Monitoring general laboratory and its maintenance activity as applicable. Responsible for performing routine analysis and stability analysis of the finished product for assay, CU, related substances, dissolution and residual solvent etc. Prepare draft STP. Review of analytical data, calibration data and qualification data Responsible for troubleshooting and maintenance of HPLC, GC, UV/Visible and spectrophotometer etc. Calibration of analytical instruments like Analytical Balance, pH meter, UV spectrophotometer, KF Potentiometer, Karl Fischer as per the schedule. Following in house systems and procedures to ensure cGMP practices and regulatory requirements. Maintenance of reference standard, working standards and their standardization. Co-ordinating the activities in Chemical and Instrumentation. Handling of Troubleshooting. To update instrument log book entries Desired Skills: Must have experience in formulation testing in reputed pharma organizations. Handling of instruments like HPLC, GC, UV, UPLC, Dissolution tester, KF, FTIR. Strong knowledge of Microsoft Word/Excel.PPT. Good Communication and problem solving skills. Should be assertive, proactive and self-driven. Should be willing to work in a dynamic work environment. Pedigree: B. Sc (Chemistry), M.Sc (Chemistry) with 3-5 years of relevant work experience.

3-5 years of experience in an EHS role with ISO audit responsibilities. Work is primarily performed in a manufacturing or industrial plant environment. – Mandatory. Strong knowledge of EHS regulations and ISO standards (e.g., ISO 14001, ISO 45001).