982 Sop Jobs - Page 10

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for compilation and review of validation raw data and test certificates. 5. Responsible for preparation and review of Computerized system validation (CSV) documents and execution of CSV for equipments. 6. Responsible for preparation of User Requirement Specification, Design Qualification, FAT protocols, SAT protocols, Installation qualification, Operational qualification and Performance qualification, Revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling and review of risk assessments, deviation, change control and incidents related to qualification activities and user department activities. 11. Responsible for preparation of Utilities Annual summary reports.

1. Preparation, review and revision of SOPs, GTPs and Work sheets. 2. Execution of analytical method validation protocols for product samples. 3. Testing and review of product / Miscellaneous samples for AET. 4. Operation and maintenance of laboratory Instruments. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Involve in the execution of Media fill validations. 7. Cleaning, verification of laboratory cleaning and glassware cleaning in the Microbiology laboratory. 8. Receipt, storage, preparation, sterilization and maintenance of sterile media and reagents. 9. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 10. Responsible for Growth promotion, inhibition test of Microbiological culture media. 11. Responsible for Biological indicator qualification, usage and testing. 12. Culture maintenance in Microbiology department. 13. Preparation and usage of disinfectants. 14. Review of outside COAs. 15. Review, checking and verification of all types Microbiology laboratory documents. 16. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;. 17. Verification of cleaning in the Microbiology laboratory. 18. Responsible for compliance to cGLP.

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS. 4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS. 5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials. 6. Operation and calibration of QC Instruments related to product testing. 7. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.) 8. Preparation of reagent solutions, buffers and maintenance of the records. 9. Temperature and humidity monitoring of labs and instruments. 10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing. 11. Withdrawal and aliquoting of batch release and stability samples for analysis. 12. Responsible for preparation of shift schedules and test planning activities. 13. Responsible for cGLP compliance. 14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 15. Responsible for change management: Ensure CRNs initiation and closure within target date. 16. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 17. Review of analytical data and work sheets related to product testing. 18. Maintenance of stability samples and reserve samples related to product testing. 19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 20. Responsible for usage, monitoring and verification of all kind of laboratory books. 21. Preparation, execution and review of reference standard qualification. 22. Maintenance of all QC documents related to product testing. 23. Assist in execution of Analytical method validations.

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations. 2.Responsible for performing in process checks during finished product operations as per respective established procedures. 3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities. 4. Responsible for preparation of IPQA SOPs and review of finished product SOPs. 5. Responsible for preparation of Annual Product Review Reports. 6. Responsible for continued process verification reports. 7.Responsible for compliance to GMP in finished product area. 8.Responsible for review of all finished product log books. 9.Responsible for review of master MFR and executed BFRs. 10.Responsible to attend training programs and SOP trainings. 11.Responsible for preparation of media fill BFR, protocol and report. 12.Responsible for monitoring of stability samples. 13.Responsible for preparation and review of visual inspection qualification protocol and report. 14.Day to Day Manufacturing observations Report to Manager QA.

1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for operation and handling of Dataloggers, HVAC related equipments. 5. Responsible for compilation and review of validation raw data and test certificates. 6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling of risk assessments, deviation, change control and incidents related to qualification/validation. 11. Responsible for preparation of Utilities Annual summary reports.

1. To perform Equipment operation and cleaning. 2. To supervise the Visual inspection and batch packing execution as per plan. 3. To perform the documentation as per Batch record and SOP. 4. To perform the equipment qualification as per protocols and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Co-ordinate to cross functional team as per day-to-day activities. 7. Responsible for SOP, MPR and BPR preparation and revision. 8. Co-ordination with team to execute daily packing and visual inspection plan. 9. Ensure the training completion before doing activity. 10. To raise batch record request as per plan. 11. Responsible for QMS related activity(Change control, Deviations, Batch record) in packing and visual inspection activity. 12. Monitor day to day activities. 13. Reporting all the activities, incidents and problems to Reporting officer

Develop the die lines/KLDs and coordinate with the vendors for new launch products on secondary and tertiary packing materials. Coordinate with vendors, PPIC, and Warehouse for material procurement. Coordinate with cross-functional teams and conduct trials for secondary packing materials Monitor day-to-day activities. Inputs on artwork design to meet marketing requirements for secondary and tertiary packaging materials. Review and approve the specifications of secondary and tertiary packaging materials for QC. Coordinate with cross-functional teams and customers for artwork preparation and approval. Review and approval of print proofs and shade cards. Review of Pack profiles. Responsible for QMS-related activities in Packaging Development. Perform documentation as per SOP Responsible for maintaining documents in compliance with cGMP norms. Responsible for the Change control and incident reporting. Responsible for pack configuration finalization. Responsible for the completion of dangerous goods (DG) and general product transport validation studies. Responsible for the implementation of functionality studies of primary packaging material Responsible for the implementation of barcode system on packaging material. Implementation of Track and Trace system for export markets Evaluation of RLD/Reference product packaging material. Development of new change parts. Provide training to team members. Ensure document compliance with regulatory requirements. Report all activities and issues to the Reporting Officer. Timely Ensuring the availability of Materials for batch manufacturing activities.

1.Preparation, revision and review of SOPs, STPs, Specifications and GTPs and Worksheets related to product testing for electrophoresis lab 2.Preparation, revision and review of analytical method Validation protocols and reports related to product testing. 3.Responsible for shift schedules and test planning activities. 4.Testing, documentation, review and release of In-process, Batch release, Stability and Miscellaneous samples. 5.Responsible for handling of OOS, OOT, Incidents, LIRs, Change controls, Deviations and Risk Assessments. 6.Preparation, revision and review of miscellaneous protocols and reports related to product testing. 7.Responsible for training of QC analysts and new joiners related to product testing. 8.Maintenance of all QC documents related to product testing. 9.Responsible for GLP compliance. 10.Responsible for calibrations, validations and PMP of instruments related to product testing. 11.Responsible for conducting internal audit of other departments as part of GMP compliance. 12.Responsible for general cleanliness of laboratory 13.Responsible for preparation for URS. 14.Responsible for Coordinating with inter and intra departments for technical discussions. 15.Responsible for samples sending and checking of outside laboratory reports. 16.Responsible for preparation and uploading of job responsibilities for new joinee or whenever employee job role change. 17.Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications.

1.Responsible for preparation of training related SOPs. 2. Responsible for preparation of induction training schedule for newly joined employees. 3. Evaluation of induction training programme of newly joined personnel. 4. Responsible for collection of specimen signatures of all newly joined employees. 5. Coordination with concerned department head, for preparation of job responsibilities. 6. Responsible for review evaluation of newly joined personnel on the job training schedule. 7. Responsible for activation, modification/deactivation of electronic access control in the facility. 8. Responsible for preparation GMPSafety training schedules. 9. Training requirements identification in coordination with concerned departments. 10. Responsible to attend the training programs. 11. Coordination for conducting trainings on SOPs and GMP trainings. 12.Responsible for LIMS and TRIMS administration activities. 13.Responsible for handling of CRNs, Incidents and CAPAs. 14.Responsible for the Custody, Issue Control of all master documents (SOPs and Specification, STPs, Protocols and Batch Records).

1. Follow SOPs, GMP and safety practices. 2. Facility Area cleaning, Equipment cleaning, drains cleaning sanitization. 70 % IPA arrangement. Discarding general waste, rejects and biowaste. Log books updation. Spillage management. Updating of BMRs and annexures online. 3. Material Arrangement of plastic / glassware. Material packing for sterilization. Arrangement of garments. Arrangement of materials. 4. Process Arrangement of drums and installation of bags. Collection of WFI. Movement of prepared media/buffer to process rooms. Assisting in cleaning of equipments. Movement of samples. Execution of production activities. Monitoring of batch parameters. Arrangement of HDPE Drums, Vessels and installation of SUM bags and liner bags. Samples handling (Sampling and labelling). Handling of Depth filters assembly and harvest activities. Media Buffer preparation activities for process. LN2 container handling for filling activities. 5. Participate in training programs as per training schedule. 6. Responsible for operation of following production equipments (but not limited to): Mixing systems Weighing balance Magnetic stirrer Peristaltic pumps pH meter Cold Room Freezer Heat exchanger Depth filter holders Laminar air flow cabinet Biosafety cabinet Pass box LN2 container

Responsible for production activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room Training: Attending training on SOP's / GMP as per schedule.

Responsible for production (downstream) activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Chromatography column and resin monitoring. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room Training: Attending training on SOP's / GMP as per schedule.

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for buffer preparation activities Area drains cleaning and documents updation. Verification and receiving of material required for buffer preparation activities. Execution of Buffer preparation activities. Preparation of area, equipments before batch activities. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Updation of room / equipment status labels. Arrangement of sterile material. 3. Handling of documents Updation of log books. Updation of BMRs and protocols/reports 4. Responsible for operation of following production equipments Mixing systems Conductivity meter Weighing balance Peristaltic pumps Walk in Cold room Freezer room Magnetic Stirrer pH meter Heat exchanger 5. Attending training on SOP's / GMP as per schedule

1. Responsible for preparation of training related SOPs. 2. Responsible for preparation of induction training schedule for newly joined employees. 3. Evaluation of induction training programme of newly joined personnel. 4. Responsible for collection of specimen signatures of all newly joined employees. 5. Coordination with concerned department head, for preparation of job responsibilities. 6. Responsible for review evaluation of newly joined personnel on the job training schedule. 7. Responsible for activation, modification/deactivation of electronic access control in the facility. 8. Responsible for preparation GMPSafety training schedules. 9. Training requirements identification in coordination with concerned departments. 10. Responsible to attend the training programs. 11. Coordination for conducting trainings on SOPs and GMP trainings. 12. Responsible for LIMS and TRIMS administration activities. 13. Responsible for handling of CRNs, Incidents and CAPAs. 14. Responsible for the Custody, Issue Control of all master documents (SOPs, Specifications, STPs, Protocols and Batch Records). 15. Responsible for Control, Issue and Retrieval of the Formats and Registers. 16. Responsible for Storage, Retrieval, Control Retention of all Completed documents (including software). 17. Responsible for issuance and reconciliation of Batch record documents. 18. Responsible for the Custody, Issue Control of Work Sheet for Record of Analysis. 19. Responsible for compliance to GMP. 20. Responsible for Allotment of batch numbers.

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

Responsible for production activities 1. Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. 2. Chromatography column and resin monitoring. 3. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. 4. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room 5. Training: Attending training on SOP's / GMP as per schedule. 6. Responsible for Quality Management Systems Initiation of breakdown request. Initiation of CRN's. Initiation of incidents, Investigations and CAPA.Please enter job description

1. Execution of production plan for formulation and filling. 2. Achieving planned FP targets with strict adherence to cGMP. 3. Execution of planned activities of Aseptic Processing Areas like media fills simulation trails, Formulation and filling activities. 4. Ensuring of sterilizing loads, cleanliness of filling room, entry and exit change rooms of aseptic areas. 5. Preparing and implementation of standard operating Procedures, Protocols, cleaning procedures and relevant log sheets. 6. On-line execution of Batch documents and related logbooks. 7. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 8. Maintaining documents as per regulatory and cGMP norms. 9. Performing day to day activities in manufacturing areas. 10. Reporting all the activities, incidents and issues to Reporting Manager. 11. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 12. Handling of SAP and DMS as per the requirement.

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Monitoring of area drains cleaning and documents updation. Updation of area / equipment status labels. Samples handling (Sampling and labelling). Arrangement of material required for activities. Assisting in Execution of production activities. Updation of BMR's. Receiving material (RM miscellaneous). Returning miscellaneous materials to warehouse. Planning and Execution of FDS thawing and dispensing activities. Assisting in product changeover activities before batch execution. Assisting column packing and execution of equipment specific protocols. Assisting in Equipment (Purification TFF system) cleaning.

1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOPs related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipments. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings. Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatory SOPs and documentation standards.

Job Description Install, configure, and maintain desktops, laptops, mobile devices, and internal networks. Manage internal network devices such switches, routers, firewall, access points etc. Manage internal systems such as Active Directory, file servers, internal applications, and intranet portals. Maintain accurate records of all IT hardware and software assets across their lifecycle (procurement to disposal). Manage software licensing, renewals, and ensure usage complies with vendor agreements. Monitor system performance and troubleshoot issues to minimize downtime. Apply OS patches and upgrades on a regular basis and upgrade administrative tools and utilities. Maintain and monitor internal backups and disaster recovery processes. Create and manage user accounts, access rights, and group policies in line with company security policies. Implement security measures including firewalls, antivirus software, and intrusion detection systems. Document internal systems, processes, and changes to infrastructure. Provide technical support to internal teams and employees for hardware/software issues. Collaborate with other IT staff to design and deploy new internal systems or services. Stay updated on emerging technologies and make recommendations to enhance system efficiency and security. Qualification Bachelors degree or Diploma in Information Technology, Computer Science, or equivalent experience. Proven experience as a system administrator, network administrator, or similar role. Minimum 2+ years of work experience. Strong knowledge of systems and network administration (Windows, Linux, etc.). Familiarity with various IT tools and platforms such as Active Directory & Microsoft 365. Excellent troubleshooting and problem-solving skills.

NKP Pharma is looking for OFFICER / EXECUTIVE / ASSISTANT MANAGER (QC) to join our dynamic team and embark on a rewarding career journey Quality Testing and Inspection:Perform routine and ad-hoc quality tests and inspections on raw materials, intermediate products, and finished goods Utilize various testing methods and equipment to assess product/service quality and performance Record and document test results accurately and in accordance with established procedures and protocols Quality Assurance Procedures:Implement and enforce quality assurance procedures and standards to ensure compliance with regulatory requirements and industry best practices Develop and update quality control documentation, including standard operating procedures (SOPs), work instructions, and quality manuals Identify areas for process improvement and recommend corrective actions to address quality issues Non-Conformance Management:Investigate and document non-conformances, deviations, and quality incidents Collaborate with cross-functional teams to identify root causes of quality issues and implement corrective and preventive actions (CAPAs) Monitor and track the effectiveness of CAPAs to prevent recurrence of quality problems Quality Metrics and Reporting:Monitor and analyze quality metrics and key performance indicators (KPIs) to assess process performance and product/service quality Prepare and present quality reports and dashboards to management and stakeholders Provide insights and recommendations for continuous improvement based on quality data analysis Training and Compliance:Provide training and guidance to staff on quality control procedures, methods, and best practices Ensure compliance with regulatory requirements, quality standards, and industry regulations Participate in internal and external audits, inspections, and quality assessments as needed

3-5 yrs of experience as CRC JD: Preparation of SOP's for operation, establishment of work/trial conduct systems/ training to new joiners/ training to trainers internal trainings, QC Visit of current project remotes, Checking weekly logs, equipment management, market Research

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clients QMS and quality training requirements. Responsible for ensuring that the work conducted by the Facilities team, and its subcontractors is in full compliance with contractual requirements, clients SOPs, GxP, FDA and other regulations. Able to perform/support internal JLL compliance audits and prepare SOPs, and training materials for use by the Life Sciences facilities team in the performance of their work. Guide Life Sciences facilities team in closing recommendations from clients audit. Expected to interface with the clients quality personnel to ensure that all of the clients SOPs are followed, work performed by the LS facilities team is properly documented for traceability in the framework of GDP. Sustain quality assurance support and develop a Quality Engineering Maintenance program for a controlled-environment manufacturing and laboratory facility as it relates to the facilities maintenance of this plant. Conduct investigations and drive accountability for all quality events. Lead programs to create value for client to ensure program deliveries meet or exceed expectations. Facilitate quality-relevance investigation via structured Root Cause Analysis. As part of career development, lead Life Sciences accounts as an IFM leader.Reporting Manage and report on critical & key performance measurements. Develop and submit periodic site status reports related to the Quality Program. People Management Effectively lead and guide a Life Sciences Quality team by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement. Ensure Life Sciences Operations team members complete relevant quality and compliance training. Coach new Life Sciences team members on quality and compliance for their adaptation into specific Life Sciences accounts. Mentor, develop and train peer and direct report team members. Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.Others Any other quality-relevant duties and tasks assigned. Knowledge, Skills & Abilities. MINIMUM REQUIRED / PREFERRED - Education/training Bachelor degree preferred Degree in science, technical or relevant discipline Sound fundamental knowledge in process utilities. 6+ Years of relevant experience preferred with minimum 4+ years in Quality and Compliance discipline in GxP manufacturing or laboratory environment. Six-Sigma and Root Cause Analysis training is essential. Skills and knowledge Background in technical documentation Work independently and within a team. Strong mindset of compliance and client-focus. Communicate effectively with technical, quality assurance and other personnel. Proficient in Word, Excel and other Microsoft Office Suite programs Ability to investigate, recognize and diagnose trends and patterns. Solid understanding of cGMPs as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing plants and laboratories for drug products. Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity. Support investigations and corrective action plans for appropriate discrepancies. Investigation of compliance issues as required, collaborating with relevant Compliance Partner(s) Understanding of FDA regulations including 210 CFR part 210 and 211. Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the site. Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems English communication is essential Other abilities Good oral and written communication skills including the ability to communicate to all levels of management and willing to interface with a diverse customer base including technical and non-technical personnel.Physical work requirements and work conditions Familiar with process utilities and GxP environment.