183 Environmental Monitoring Jobs

You are invited to join Horizon Biolabs Pvt Ltd., a GLP compliant Pharmaceutical Testing Laboratory based in Hyderabad, India. We are a global leader in providing laboratory testing services in Chemical and Microbiological segments for the pharmaceutical, biotech, and medical devices industries. We are looking for candidates with an MSc in Microbiology and a minimum of 6 months to 1 year of experience in a reputed Pharma Testing Lab, CRO, or Pharmaceutical Industry. Your responsibilities will include conducting Microbial enumeration tests, Antimicrobial Effectiveness Test (AET/PET), Sterility, Bacterial Endotoxin Test (BET by Gel Clot), Environmental Monitoring, Microbiological Assays, and Water validation. You should also have experience in protocol preparation, report preparation, and Method Validations. As a Microbiologist at Horizon Biolabs Pvt Ltd., you will oversee and manage all microbiological activities, supervise a team of microbiologists, review and interpret test results, identify process improvements, maintain documentation, collaborate with cross-functional teams, and ensure compliance with regulatory requirements. You will be the single point of contact for day-to-day operations in the Microbiology Laboratory and will represent the laboratory during customer and regulatory audits. This is a full-time position with benefits including Provident Fund. The work schedule is a day shift, and the work location is in person at our facility in Hyderabad, India. The application deadline is 05/04/2025, and the expected start date is 10/04/2025. If you meet the requirements and are ready to take on this exciting opportunity, we look forward to receiving your application.,

Job Title : Sales Manager Location : Chennai Company : Aurassure Industry : Climate Technology / Environmental Services Department : Sales Employment Type : Full-Time Company Description Aurassure is a climate tech startup building solutions for a sustainable world. We have various in house designed and patented products to offer for Air Quality Monitoring, Flood Monitoring and Weather Monitoring. The company provides innovative climate management solutions that help businesses to monitor and analyze air quality and urban floods in real-time. Role Description Youll be working with the Founding team. This team runs on an infectious passion for solving the biggest challenge of solving climate change through data by building partnerships with enterprises. The candidate will be responsible for identifying new business opportunities, achieving sales targets, and building and maintaining strong relationships with customers. The role will involve creating and delivering effective sales presentations, negotiating deals, and driving revenue growth. He/She will primarily target B2B and B2G clients and will be expected to travel frequently to meet existing clients or generate new ones Key Responsibilities Identify and connect with potential clients in sectors such as Construction, Real Estate, Health Care, Industries, Enterprises aligning their needs with Aurassures projects. Promote and sell Aurassures solutions, including air quality monitoring systems, flood monitoring and weather forecasting stations. Conduct frequent client meetings, both existing and prospective, to generate new leads and close sales deals. Deliver compelling sales presentations to demonstrate the value and impact of real-time environmental monitoring on sustainability and public health. Negotiate contracts and finalize agreements to meet and exceed revenue targets. Build and maintain strong relationships with clients, ensuring satisfaction and opportunities for repeat business. Stay updated on industry trends, market demands, and regulatory changes related to environmental monitoring. Qualifications Proven experience in sales or business development, preferably in environmental services, technology, or related industries. Strong communication, presentation, and interpersonal skills. Excellent negotiation and deal-closing abilities. Familiarity with CRM tools and sales tracking software. Any Bachelors degree or a related field; an MBA is a plus. Why Join Aurassure Join a passionate team dedicated to addressing critical environmental challenges. At Aurassure, you will play a key role in implementing innovative air quality and climate monitoring solutions that contribute to a more sustainable and resilient future. Application Details Aurassure is an equal-opportunity employer committed to diversity, equity, and inclusion. Applications are reviewed on a rolling basis, so apply promptly to become part of our vibrant Skills: negotiation,sales tracking software,business development,interpersonal skills,crm tools,crm,presetantions,communication,presentation,deman generations,sales,sales pitch,deal closure,environmental monitoring,new leads,negotiations,b2b Show more Show less

Key Responsibilities: Conduct routine environmental monitoring and assessments in various locations Collect, analyze, and interpret environmental data using specialized equipment and software Maintain accurate records and documentation of environmental conditions Communicate findings and recommendations to stakeholders and management Participate in environmental remediation and restoration projects Ensure compliance with environmental regulations and standards Growth promotion test, Media preparation, Autoclave operation, Cleaning and disinfectant preparation. Calibration of instruments.

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Under the guidance of Manager-Instrumentation / R&D , responsible for installation, maintenance and calibration of all the instruments in Apotex Research Pvt Ltd as per GMP/GLP requirements. Also responsible to generate and maintain laboratory equipment documentation. Job Responsibilities Conducts duties following established Apotex Research Pvt. Ltd., Standard Operating Procedures and in a consistent manner consistent with current regulatory (GMP, DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations. Perform maintenance and calibration of analytical instruments like HPLCs, GCs, pipettes, balances, etc and maintain instruments in good working order. Monitor and support during instruments installations and qualifications. Prepare and revise instrument related SOPs. Assists and involve in preparation and execution of documents for software validations. Maintain/Oversee all the instrument related qualification files, software validation reports, routine calibration records their scheduled archiving. Arrange vendor engineers for maintenance/calibration and maintain necessary AMC contracts with vendors. Update and maintain the Master list of instruments and calibration schedules. Monitor freezer/environmental monitoring system and respond to the alarms. Documents all the work and results of all assignments as required. Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management. Ensures that all work is performed in compliance with all pertinent SOP, GLPs, GALP and Safe Work Practices. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Minimum BE / B.Tech / M.Sc. Instrumentation. 2 to 4 years of experience in Instrumentation of AR&D, Bioanlaytical lab, QC labs. Experience with analytical laboratory equipment like HPLC, LC/MS/MS, GCs etc. for trouble shooting, repairs, calibraitons, qualifications, etc. Fundamental understanding of concepts of GMP, GLP, GCP, 21 CFR Part 11guidelines. Computer skills in laboratory data acquisition software(s), spreadsheets and word processing. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Core Responsibilities: Develop EIA documents (Forms I, IA, PFR, etc.) Manage Parivesh & other online platforms Coordinate with clients& government agencies Site visits, field studies,& public hearings Prepare EIA reports & ensure project compliance. Annual bonus

Maintain media stock and reconcile records of media used in analysis. Perform water sampling and analysis following defined SOPs/protocols and ensure proper documentation. Report and log OOS (Out of Specification), OOT (Out of Trend), and EM (Environmental Monitoring) excursions. Conduct environmental monitoring of the laboratory. Perform analytical validation, culture maintenance, and growth promotion testing (GPT) of media; record observations and generate reports. Carry out microbiology laboratory tests such as Bioburden Analysis, MLT (Microbial Limit Test), Sterility Testing, BET (Bacterial Endotoxin Test), etc., in compliance with approved procedures. Skills and Proficiency: Microbiology Instrumentation Handling Expert Good Laboratory Practices (GLP) & Documentation Accuracy Practitioner Data Integrity & Documentation Practitioner Regulatory Compliance Practitioner SOP Preparation & Revision Practitioner BET & Sterility testing expertise and evaluation skills Expert Interpretation of Resulting Data Trend Practitioner Laboratory Instrument qualification, Calibration & Maintenance Practitioner Quality Control & Compliance Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) Beginner CAPA, Deviation, and Change Control Management Beginner

Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. Responsible to perform the environment monitoring activities Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible for review of executed BMRs and BPRs. Responsible to perform the in-process test at different stages as per batch document/SOP. Responsible to review the environment monitoring, water trends. Responsible to review the different type of planner and calibration certificates. Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. Responsible to monitor cGMP compliance at shop floor. Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. Environmental monitoring of manufacturing clean room area as per the defined schedule. Responsible to participate in media fill simulation study. Responsible to participate in perform qualification activities of manufacturing area. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. Compressed air /nitrogen gas monitoring and Personnel monitoring. Review of Media fill CD. Review of Visual inspector qualification record. Skills: Environmental Monitoring (EM) - Expert In-Process Quality Controls (IPQC) & Sampling - Practitioner Aseptic Process Simulation (Media Fill) Monitoring - Expert Line Clearance & Batch Record Review - Practitioner Good Documentation Practices (GDP) - Practitioner Regulatory & Compliance Knowledge - Practitioner

About The Role : Job TitleTFL Lending, Associate LocationBangalore, India Role Description We are seeking a detail-oriented and analytical professional to join our team as an Analyst responsible for performing balance sheet spreading of corporate clients using the BARS (Balance Analysis and Risk Scoring) system . This role is critical in supporting credit risk assessment and financial analysis processes. Lending Operations team is responsible in managing Lifecycle events on Syndicated Loan Deals, which provides Middle Office and Back Office support to Corporate and Investment banking divisions of the bank. The team is also involved in various aspects of recording and maintaining all Middle and Operational Roles of Loan Life Cycle includes trade support, trade documentation, trade settlements, cash reconciliation, Drawdown, Re-pricing, Payment. Team works closely with stakeholders in the Finance, Credit and technology divisions for multiple business lines such as Distressed Product Group (DPG), Commercial Real Estate (CRE) Global Credit Trading (GCT), Credit Solutions Group (CSG), and Structured Trade & Export Finance (STEF) etc. The role is demanding, complex & critical in nature and requires interaction with Front Office, Business, CRM Finance, Sales, Agent Bank and Clients. What well offer you , 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Accurately spread financial statements (balance sheet, and income statement) of corporate clients into the BARS system. Analyze financial data to ensure consistency, accuracy, and completeness. Collaborate with credit officers and relationship managers to clarify financial inputs and resolve discrepancies. Maintain documentation and audit trails for all financial spreads. Ensure compliance with internal policies, regulatory requirements, and data quality standards. Support periodic reporting and data validation exercises. Maintains the highest level of confidentiality with all information obtained. Meets expectations for attendance and punctuality. Manage the daily operations of the department in an efficient and effective manner Establish and maintain an efficient and productive working environment within the department based on continuous and effective staff communication. Participates in the review and recommendations of operational systems and procedures Communicate with management team to coordinate system and control activities Your skills and experience Considering the demanding, complex & critical nature of the role and able to work in fast passed environment with consistent deadlines, candidates should meet the below requirements. Bachelors degree in Finance, Accounting, or a related field. German Language proficiency B1 and above Strong understanding of financial statements and accounting principles. Proficiency in Microsoft Excel; experience with BARS or similar financial spreading tools is a plus. 5+ years of experience in financial analysis, credit risk, or a similar role. High attention to detail and accuracy. Strong communication and collaboration skills. Excellent verbal & written communication along with dynamic & confident approach. Flexible with Shift. Ability to implement tasks and projects with minimal supervision. Team player who fosters team spirit in a global setting. How well support you . . . .

Water testing Sterility Testing BET (LAL) Testing Media Preparation Sub- culturing Environment monitoring Serial dilution GPT testing Micro documentation working Handling of instrument as BOD Incubator Autoclave weighing Balance pH meter TDS meter Microscope

Key Responsibilities: Environmental Monitoring: Perform routine environmental monitoring of cleanrooms and controlled manufacturing areas. Monitor viable and non-viable particulates in aseptic and non-aseptic areas. Collect surface, personnel, and air samples following standard protocols. Water Sampling & Testing: Conduct regular sampling and microbiological testing of purified water (PW), water for injection (WFI), and other utility systems. Analyze total microbial count and alert/action limits as per pharmacopeial and regulatory guidelines. Microbial Testing: Perform microbial limit tests on raw materials, finished products, and in-process samples. Identify and document any out-of-specification (OOS) or out-of-trend (OOT) results, initiate investigations, and support CAPA processes. Maintain test logs and laboratory notebooks accurately and in compliance with data integrity standards. Media Preparation: Prepare and qualify culture media and reagents as per SOPs and quality requirements. Ensure proper storage, labeling, and sterility of prepared media. Maintain media inventory and monitor expiry dates. Compliance and Documentation: Adhere to current Good Manufacturing Practices (cGMP) and relevant pharmacopeial guidelines (USP, EP, JP). Maintain and review laboratory documentation including SOPs, logbooks, test records, and equipment usage logs. Participate in internal and external audits, providing necessary documentation and support.

Walk In Drive For Microbiology Department In Formulation Division @ Bollaram Department :- Microbiology Qualification :- BSc | B Pharmacy | MSc | M Pharma Experience:- 2 to 5 Years Division :- Formulation Interview Date:-30-07-2025 Interview Time:- 9AM TO 2.00PM Work Location :- MSNF-I, Bollaram Venue Location :- MSN Laboratories Pvt Ltd (Formulation Div I) Plot No:-42,Anrich Industrial Estate, Bollaram Village, Hyderabad, Telangana-502325. (View on map) Note:- Candidate should bring Update Resume , Increment Letter, Payslips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

As a Micro Lead API at our Ahmednagar location in the grade of G9B- Sr. Manager 2, your primary responsibility will be to plan, review, and monitor all activities within the Microbiology department. You will lead the department, ensuring smooth coordination with other departments to prioritize tasks and provide timely support and testing to prevent delays in analysis. Your role will involve reviewing all departmental documents and results in the LIMS system specifically in the microbiology section. You will oversee the lysate sensitivity test, Bacterial endotoxin test of WFI and API products, as well as validate the bacterial endotoxin test and microbial quality of products. Additionally, you will be responsible for the procurement, receipt, storage, maintenance, and reconciliation of biological indicators, media, reagents, standard cultures, and bioball. Calibration and operation of the TOC analyzer, environmental monitoring activities, qualification, and calibration of all instruments in the microbiology laboratory will also fall under your purview. Participating in investigations, reviewing deviations/OOS/OOT/OOC/Lab Event, and SOP revisions in the micro section online are crucial aspects of your role. You will need to maintain logbooks, prepare and review GMP documents, ensure fumigation activities, and review trends for water and environmental monitoring. Adherence to online good documentation practices, validation of autoclave, Dry heat sterilizer (DHS), Incubators, Laminar Air flow, HVAC, preparation of reagents, inventory, and stock record maintenance, GLP compliance, and safety protocols are essential responsibilities. Furthermore, you will be expected to support review and compliance activities in the quality function, coordinate with corporate functions regarding microbiology activities, and follow any other responsibilities assigned by the Quality head. Graduates in Microbiology or equivalent with experience in Micro testing/leading are encouraged to apply.,

for Internal Candidates To perform Machine and area clearance during dispensing, manufacturing and packaging operation. To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids. To carry out in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol,BMR, BPR, SOPs and other GxP documents. To ensure GMP practices at manufacturing shop floor. To verify raw material dispensing activity. To approve batch coding details during packaging operation. Review of executed batch records and release for next processing stage. Preparation and review of CPV data trend. To perform impact assessment of breakdown memo. To initiate change control, unplanned and planned deviation where ever required. To review area, equipment and cleaning log and to ensure proper labelling. To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records. To perform calibration of IPQA instruments. To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials. To review and approve packaging artworks, proofs and shade cards. To archive executed documents like BMR, BPR, Hold time Protocol etc. To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging. To monitor and record the environmental condition of label control room. To prepare and revise functional SOPs, wherever required. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.

To perform Machine and area clearance during dispensing, manufacturing and packaging operation. To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids. To carry out in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol,BMR, BPR, SOPs and other GxP documents. To ensure GMP practices at manufacturing shop floor. To verify raw material dispensing activity. To approve batch coding details during packaging operation. Review of executed batch records and release for next processing stage. Preparation and review of CPV data trend. To perform impact assessment of breakdown memo. To initiate change control, unplanned and planned deviation where ever required. To review area, equipment and cleaning log and to ensure proper labelling. To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records. To perform calibration of IPQA instruments. To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials. To review and approve packaging artworks, proofs and shade cards. To archive executed documents like BMR, BPR, Hold time Protocol etc. To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging. To monitor and record the environmental condition of label control room. To prepare and revise functional SOPs, wherever required. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Role & responsibilities Planning of day to day microbiological activities Drug substance and drug product related documentation Communication with Production & QA, Engineering for day to day update Stability study of drug substance & product BTR review Preferred candidate profile Knowledge of General Microbiological GMP/GLP awareness Current guidelines like D&C act or schedule M knowledge of FDCA requirements Job Location : Kadi Gujarat (Bus facility are available)

You will be responsible for ensuring line clearance for the start-up of the tablet section including compression, coating, and capsule filling areas. Additionally, you will be in charge of accurately filling logbooks for the Tablet section, manufacturing area, and grinding section. Your duties will also include conducting in-process sampling of tablets and final sampling, as well as carrying out online reviews of Batch Production Records (BPR) for Tablet, Capsule, and Jawkut sections. Monitoring environmental conditions in the respective operational areas will be another key aspect of your role. Issuing tablet excipients and empty capsules and checking online parameters of Tablet and Capsule will also be part of your responsibilities. This is a full-time, permanent position with benefits such as internet reimbursement, leave encashment, and paid sick time. The work schedule will be during the morning shift. A background in pharmaceuticals or herbal medicine is preferred, and a Bachelor's degree is preferred for this role. The work location will be in person.,

You will be responsible for conducting environmental monitoring in the In-Vitro Diagnostics production areas, Large Volume Parenterals production areas, and Microbiology Department. This includes filling out the related documentation for Environmental monitoring. Your role will involve analyzing the sterility test of finished/bulk/raw materials and documenting the results. Additionally, you will be responsible for performing the Bacterial endotoxin test on finished/bulk/raw materials. You will also analyze the Bioburden of bulk/raw materials and maintain detailed records of Temperature monitoring and relative Humidity in the analysis area log book. Water testing is a crucial part of the job which includes testing Raw water, purified water, and water For Injection (MLT and Pathogen testing) and documenting the results. You will also be responsible for conducting Microbial limit tests on raw materials and documenting the findings. Operating the steam sterilizer and vertical autoclave will be part of your duties, including filling out the related documentation for these operations. Another important task will be performing the Bacterial endotoxin test on water for injection. Additionally, you will need to conduct DOP on plates for all sections IVD, LVP, MBD and perform Gram staining tests while maintaining detailed records of these tests.,

Common Responsibilities: Adherence to all procedures related to data integrity Ensure there is no violation of any environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety Always wear all required PPE. Understand and demonstrate that you are responsible for safety of self & colleagues by following all necessary safety protocols at all times Identify near-misses and potential incidents proactively and communicate those Report any non-conformities/ Deviations to manager. Ensure on-time completion of the assigned trainings and ensure compliance with the training procedure and training calendar. Participate/support trainings on procedures, protocols and On-the-Job activities. Specific Responsibilities: Cleaning and fumigation of area Maintain records as per the approved procedure. Operations of autoclave and filter integrity machine. Cleaning of production accessories. Preparation of cleaning solutions Maintenance of stock of consumables Monitoring of Environmental Monitoring system. Garments management of BMP5 operations. Operations of kill system and decontamination autoclave. Preparation of load articles before autoclaving.

Experience: 6 - 8 years of experience in Quality Assurance / Quality control of sterile dosage manufacturing facility. Core Competencies Change Management process Risk assessments principles and tools Validation of lab equipment s Drug Product Process validations Regulatory requirements Compendial Changes Technical Skills Knowledge in validation principles and practices related to the Process validation, cleaning validation, Analytical Method validation, Water system, HVAC system, Equipment & Utility Qualifications. Knowledge of various Quality tools required for investigations Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization Knowledge in change control assessment Knowledge on Chemical and Microbiology analysis. Basic idea on manufacturing operations, validation and engineering functions Experience in handling Regulatory agency inspections Behavioral/Any Other Skills Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship Managerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills. Acts Decisively: Makes decision in a timely manner based on available information Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives Self-accountable & Proactive approach Critical thinking and Compliance mindset Core Responsibilities Partially/fully independent, reviews critical change controls and protocols, trains others. Responsible for review & approval of documents as per current regulatory requirements. Assessment, approval & closure of change control and action items Site change review committee (SCRC) meeting with cross functional team to assess the change before initiation in gqts and present the critical change controls to the leadership team for its adequacy. Coordinating with CFT for addressing & resolving of Review Comments for timely Closure. Review & approval of Sops, Job aids, forms, Quality Risk Assessment (QRA), validation protocols, study protocols & summary reports. Review and approval of STP s and specifications. Review and approval of stability compilation reports. Review and approval of APR s. Review and approval of Environmental monitoring trends, Water monitoring trends, bioburden, BET, sterility trends, isolate trends and summary reports. Ensure manufacturing policies, procedures conform to Pfizer Report any non-compliance to the Manager Experience in handling regulatory, corporate and internal auditors/ inspectors. Work Location Assignment: On Premise Quality Assurance and Control #LI-PFE

Role & responsibilities Quality Control: Qualification: B. Pharm/ M. Pharm / M. Sc chemistry Experience: 1 to 6 years of experience in Pharmaceutical Quality Control experience. Job Description: Perform HPLC analysis. Familiarity with analytical laboratory equipment's like HPLC, GC, AAS,ICP-MS, UV, IR and etc., Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments. Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions. Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies. Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current. Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database, and generate EMS reports. Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction. Demonstrated technical skills in method validation and testing Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations Knowledge of Good Manufacturing Practices and its application standards, processes, and policies. Excellent organizational skills and strong ability to multi-task Strong written and verbal communication skills Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography) techniques Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records. Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories. Perform testing on various samples, manage Laboratory Information Management System builds. Detail-oriented with robust knowledge of quality control process Effective written and verbal communication, as well as interpersonal skills Experience with Laboratory Information Management Systems (LIMS) Quality Control - Microbiology Qualification: M. Sc(Microbiology) Experience: 1 to 6 years of experience in Pharmaceutical Quality Control - Microbiology. Demonstrated technical skills in microbiology testing Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures Assist in the preparation and maintenance of media stocks, including sterilization of accessories by autoclave cycles. Manage receipt, storage, and handling of Bio ball cultures, and assist in the maintenance of Master cultures and preparation of Cryo vials. Perform various microbiological tests such as water analysis, Microbial Limit Test, , Bacterial Endotoxin Test, Ensure training records are updated and correctly filed to reflect current testing capabilities. Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments. Conduct analyses on finished products, raw materials, and components, including data entry, review, Effective written and verbal communication, as well as interpersonal skills

You will be responsible for coordinating environmental monitoring activities through an external laboratory on an alternate-month basis, which includes monitoring Air, Water, Noise, etc. You will need to follow up and ensure compliance with environmental requirements during audits such as Decathlon, IMS, SA8000, and other related assessments. Additionally, you will handle all activities related to TNPCB, including applying for CTE, CTO, HWA, and other relevant permits or renewals. Managing the disposal and documentation of all categories of hazardous and non-hazardous waste will be part of your responsibilities. You will also be required to prepare and maintain all necessary environmental documentation and records. This is a Full-time position with benefits including Leave encashment and Provident Fund. The work schedule may include Day shift and Rotational shift. In addition to the salary, a Yearly bonus may be provided. The ideal candidate should have a total of 3 years of work experience, with experience in similar roles being preferred. This position requires you to work In person at the designated work location.,

The QC Microbiologist I position involves performing various microbiological testing activities, such as water testing, environmental monitoring, media preparation, and growth promotion of media, under minimal supervision. In addition to conducting raw material testing, finished product testing, stability testing, antibiotic assay testing, gram staining, and microbial enumeration suitability testing, the role also includes antimicrobial effectiveness testing and other required microbial testing. The position requires maintaining quality and efficiency in all tasks performed. Responsibilities include routine water testing, media preparation, growth promotion of media, and environmental monitoring. The role also involves ensuring cleanliness and organization in shared laboratory areas, participating in stock inventory management, and conducting routine Microbial Examination Testing. Additionally, assisting with microbial suitability testing, antimicrobial effectiveness testing, antibiotic assay testing, gram staining, and other microbial testing is part of the job scope. Adherence to Environmental, Health and Safety policies and procedures is essential, along with flexibility to work overtime or weekends occasionally as needed. The ideal candidate should possess specialized knowledge of aseptic technique, environmental monitoring, and microbial examination methods. Familiarity with FDA, USP, ICH, cGMP, and cGLP requirements in a pharmaceutical quality control laboratory is necessary. Proficiency in LIMS, Microsoft Office Suite, and electronic data management systems is also required. Key qualifications include strong organizational skills, attention to detail, multitasking abilities, adaptability to changing priorities, ownership of tasks, proactive problem-solving approach, interpersonal and communication skills, and effective time management. The role may involve lifting/moving weights up to 10 lbs. and occasionally 25 lbs., handling hazardous and non-hazardous materials, and wearing Personal Protective Equipment as needed. Education requirements include a B.S. in microbiology, biology, or a related life science field. Candidates should have 0-4 years of related pharmaceutical microbiology experience and knowledge of autoclave usage, media preparation, aseptic technique, balance use, pH meter, environmental monitoring, and general plating practices. The ability to independently perform assigned tasks from start to finish without errors, including standard, sample, and reagent preparation through data processing and submission, is essential. This is a full-time position based in USA-650 Cathill Road, Sellersville, PA, 18960, US, with job identification 90441128 in the Quality Control category.,

Division Department Sub Department 1 Job Purpose Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards. Key Accountabilities (1/6) Analyse and review samples based on work allocation to meet the service level agreement Analyse samples as per priority and work allocation Review the data as per respective specification, Microbiological Methods and results obtained Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA Key Accountabilities (2/6) Report errors, abnormal observations, non-compliances related to procedures, equipment and instruments, and deliver results promptly to facilitate timely action and avoid delay in releases Initiate investigations and take necessary corrective and preventive actions Investigate incidence & lab error on priority basis so that batch release timely and issues are not recurring Key Accountabilities (3/6) Document entries, raw data and findings concomitantly in relevant test data sheets so as to facilitate the lab QA to review the reports and avoid missed entries Review reports as per cGMP & GDP for compliance to GLP Ensure no GMP / regulatory concern are raised by adhering to SOPs and following procedures Key Accountabilities (4/6) Evaluate & document Instrument / equipment break down and suggest mechanisms to avoid the same Maintain equipment and instruments optimally to ensure no incidences or non-compliances occur due to malfunctioning of equipment/ instruments Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Availability of Validation records of analysis samples becomes a challenge in cases where validation is performed on other sites. Material and resource availability becomes a challenge due to conflicting priorities between labs and coordination between analysts which makes it tough to fulfil SLA Key Interactions (1/2) Units for receiving specification, documents, protocols, area availability etc. (daily) QA/QC for product sample release (daily) Stores for procuring materials (need basis) Communicate if any observation find on the specification. Key Interactions (2/2) CQA for procuring pharmacopial guidelines (need basis) Dimensions (1/2) Review and release approximate 15 MLT reports on daily basis to achieve the SLA. Review and release approximately 15 sterility batches on weekly basis and 15 bio load samples. 50 Water Samples analysis and release 10 Technical Information Sheets for swap analysis 6 Autoclave & DHS Operation 200 locations released on daily basis for Environmental monitoring Dimensions (2/2) Key Decisions (1/2) Daily Media and Plates requirement (to Team Leader Microbiology) Key Decisions (2/2) Education Qualification M. Sc (Microbiology) Relevant Work Experience 1-5 years experience for analyst and 3-7 years for reviewer in Microbiology Good knowledge of Microbiology, skill to perform assigned task, communication in English

Role & responsibilities To follows cGLP and cGMP in the laboratory. To ensure good housekeeping and maintenance of cleaning record. To execute the microbiological activities and related documentation. To perform the sampling & testing of water (chemical and microbial analysis). To perform the environmental monitoring of the microbiology lab and production area and related documentation. To procure and maintain microbial cultures. To prepare and document disinfectants used for regular cleaning and sanitization of microbiology laboratory. To execute the testing or operating procedure as per current and approved SOPs. To calibrate the Instruments and equipment’s like pH meter, Conductivity meter, Balance etc. To co-ordinate with microbiologist in routine analysis. To Intimate and handle the change control, deviation, out of specification & out of trend. To perform the MLT of raw material, finished product, semi-finished product, stability samples, packing material samples or any other samples. To perform the analytical method validation of the product and related documentation. To perform the Bio Assay & preservative efficacy test and related documentation. To maintain and review the documents and log books which are used in routine analysis. To prepare and standardize volumetric solutions, reagents and indicators. To perform the work given by head microbiologist. To ensure the implementation and compliance with GMP aspects as trained on. To uphold the requirements of data integrity in all activities performed and monitored. To ensure compliance with integrity of data as trained on.