Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of change controls, deviations, Investigation and CAPAs and closure of the same. Tracking of QMS activities and coordinating with cross functional departments to complete the QMS activities like investigation for OOS, complaints, deviations. Identification, preparation and implementation of SOP’s. This position will prepare SOPs related to the machines which are undergoing commissioning and procedures which are proposed to implement in Drug product area. Preparation and review of URS, CLIA, SLIA, QRM, IQ and OQ documents. Involvement in the qualification activities of equipment and area in drug product area People: Champion the OneSource Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan. Preparation and execution of training modules on SOP’s in the department. Preparation and execution of QMS documents in the department. Preparation and execution of training modules on QMS and safety SOP’s in the department. Preparation and execution of training on soft skills to develop the team. Finance: Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product, process or site.
Strategic: Work towards continues improvements in automation & instrumentation to bring down the cost and technology advancement. Plant upgradation works planning, execution on Periodical basis. Able to visualize & plan the activity related to overall Project execution. Plan & execute the work towards the management goals. Able to handle DS and DP equipment’s Updated & aware of GAMP5, cGMP, statutory guidelines & standards requirements for automation and instrumentation. Plan for implementation of Automation layers Aware & update the latest software related to Automation & Instrumentation, DP, DS. Operational: Monitor the overall activity of Automation and Instrumentation activities. Plant level Automation and instrumentation breakdown diagnostics and maintenance for DP, DS, QC, EMS, BMS & Utilities. Support to Automation Layers implementation and validation. Calibration management including planning, execution, documentation and control for the plant level. Automation to support for upstream and downstream processing of MAbs/therapeutic proteins such as microbial, cell culture, chromatography, TFF, blast freezing, CIP/ SIP etc. Technical site support for CCTV, Access control, Door interlock. However main responsibility of maintaining & trouble shooting, planning & execution rests with facility management department. Coordinate with EHS team for trouble shooting of Fire alarm, PAS, VESDA & Gas suppression system. Technical site support for IT team for Data & Internet connectivity. However, main responsibility of maintaining & trouble shooting, planning & execution rests with IT department. Preparation/Review of SOP, Preventive Maintenance schedule/planner, Documentation etc. Coordination with user departments & plan for Preventive/Breakdown/ Calibration maintenance. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. And Coordination with user departments & plan for Preventive/Breakdown maintenance. Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. Support Audit & follow Statutory Compliance. Review & approval of P & ID along with control & function layout drawings and electrical drawings. Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. Monitoring of outcome agency for plant operation. Review & coordinate for finalization of agreements. Preparation and execution of QMS documents in the department. Goal setting to team members & annual review. Providing the same to the department head for review & approval. People: Shift scheduling, Manpower planning, reporting & Shift operations. Contract / Service provider Manpower/activities planning, reporting.
Conduct routine and in-process testing of sterile products according to SOPs and GLP. Support Central Lab operations including sample preparation, testing, and documentation. Perform microbiological and physicochemical tests under sterile conditions. Record and report test data accurately in compliance with GLP and GMP standards. Maintain lab equipment, clean work areas, and follow aseptic techniques. Assist in investigations related to product quality deviations as needed. Follow safety, hygiene, and contamination control procedures strictly.
Assist in preparing and submitting regulatory documentation for sterile products (e.g., FDA 510(k), CE Technical Files, DMFs). Support regulatory strategy development and maintain knowledge of global sterile product regulations. Help manage product registrations, licenses, and renewals in various markets. Collaborate with R&D, Quality, and Manufacturing teams to ensure regulatory compliance during product development and changes. Track regulatory requirements, guidance updates, and assist in audit preparations. Maintain organized regulatory files and documentation.
Perform routine and non-routine QC testing in the Central Laboratory according to SOPs and regulatory requirements. Lead or support investigations related to out-of-specification (OOS), out-of-trend (OOT), and other quality deviations. Collect and analyze data to identify root causes and recommend corrective and preventive actions (CAPA). Collaborate with cross-functional teams (Quality Assurance, Production, R&D) during investigations and product release. Prepare and maintain accurate investigation reports, lab records, and documentation in compliance with GMP and corporate policies. Support stability studies, method validations, and lab audits. Ensure lab equipment calibration, maintenance, and compliance with safety standards.
Design and develop primary and secondary packaging systems for sterile products, including pouches, blisters, trays, cartons, and labels. Ensure packaging designs comply with applicable regulatory and quality standards (e.g., ISO 11607, FDA 21 CFR, EU MDR). Collaborate with internal teams and external vendors to select appropriate packaging materials compatible with sterilization methods (EtO, gamma, steam). Lead or support packaging validation activities, including integrity testing, aging studies, and distribution testing (ASTM/ISTA protocols). Generate and maintain technical documentation, including packaging specifications, protocols, validation reports, and change control documentation. Troubleshoot packaging issues related to design, material compatibility, or process variability and implement corrective actions as needed. Participate in risk assessments, root cause analysis (RCA), and continuous improvement projects related to packaging. Support regulatory submissions by providing packaging-related data and documentation. Maintain awareness of emerging packaging trends, sustainability efforts, and regulatory changes.
Lead and oversee Environmental Monitoring (EM) of controlled areas Review and approve microbiological testing reports (sterility, BET, bioburden, MLT). Manage aseptic process validations, media fills, and gowning qualifications. Ensure compliance with regulatory guidelines (USFDA, MHRA, EU, WHO). Handle deviations, OOS/OOT, CAPA, and change controls related to microbiology. Conduct internal audits and face regulatory inspections. Train and guide microbiology team members; manage workload and shift planning. Approve SOPs, protocols, and EM trend reports.
Perform Environmental Monitoring of cleanrooms: settle plates, active air, surface, and personnel monitoring. Conduct microbiological testing: sterility, BET, bioburden, and microbial limits. Support aseptic processing, media fills, utility sampling, and disinfectant efficacy studies. Maintain documentation as per GDP; support audits and regulatory inspections. Assist in deviation handling, SOP preparation, and data trending.
Perform decartoning (removing items from outer packaging) Assist in washing and drying of parts or materials as per SOPs Maintain cleanliness and compliance in controlled areas Handle materials carefully to prevent contamination or damage Support documentation and recordkeeping for washing and decartoning activities
Execution and documentation of the Pre-formulation studies Execution of Lab scale experiments (Feasibility trials), product and process parameter optimization employing the concept of Quality by Design. Execution of process evaluation, optimization, scale-up and exhibit batches. Record primary data of experiments performed and prepare data for reports; report and discuss results, issues and work-in-progress with the senior colleagues Coordinate with other departments for material procurement, analytical data etc. Prepare documents related to the product development such as Product development plan, Stability protocols and Product development reports Document the formulation activities in PLM as per SOP, handle QMS events, LIMS, OAMS and SAP Adhering to the GLP practices
Conduct preliminary review of: Batch Documentation Certificates of Analysis (CoAs) Change controls, deviations, and investigations Support preparation, review, and maintenance of: Specifications Test methods Master Manufacturing and Packaging Records Product artworks and labeling components Coordinate with contract manufacturing organizations (CMOs) for resolution of documentation queries and ensure timely turnaround. Assist in documentation for supplier qualification and product transfers. Maintain and update product master data in SAP, including: Material codes Specifications and test parameters Change control linkages Artwork version control Track and report progress on key quality actions and compliance metrics. Assist in preparing for regulatory and customer audits. Ensure proper documentation archiving, version control, and compliance with document retention policies.
Serve as Quality Lead for outsourced manufacturing operations (CDMO/LL), ensuring robust compliance with cGMP (FDA, EU, ICH, PIC/S). Draft, review, negotiate, and manage Quality & Technical Agreements with contract manufacturers. Oversee and approve Change Controls, Deviations, Investigations, and CAPA activities; ensure timely and risk-based closure. Lead technical review and approval of batch documentation, including BMR/MMR, COAs, specifications, test methods, artworks, and master records. Act as key interface between contract manufacturing sites, internal teams (Supply Chain, Regulatory, QC), and customers to resolve quality issues and queries. Conduct or support audit readiness activities—supplier audits, internal/external quality audits and customer inspections. Maintain and enhance elements of the Quality Management System (QMS)—document control, change management, training, vendor management, metrics and continuous improvement. Where applicable, support process validation oversight, technology transfer activities, and product lifecycle documentation.
Manage day-to-day quality operations and documentation reviews related to contract/loan-license manufacturing of soft gel capsules. Review and ensure timely closure of: Deviations and Investigations Change Controls CAPAs Coordinate the review of Batch Documentation, Certificates of Analysis (CoAs), and related product quality documentation. Facilitate communication and resolution of quality matters between: Manufacturing sites (CDMO/LL partners) Internal departments (Supply Chain, QC, RA) External customers (on quality queries/documentation) Support management of product-specific documentation such as: Specifications and Test Methods Master Manufacturing Records (MMRs) Packaging components and artworks Track progress of quality actions and drive adherence to quality KPIs and timelines. Assist in supplier qualification processes, including documentation collation and audit support. Prepare for and support internal/external audits and regulatory inspections. Train junior quality staff and foster a culture of compliance and continuous improvement.
Job Purpose: Responsible for DS (MCM and CCM) IPQA activities. Primary Responsibility (Strategic, Operational, People, Financial responsibilities) Strategic: 1. Maintain data integrity in all activities at site and ensure appropriate and adequate traceability. 2. Preparation, review and implementation of Standard operating procedures, Protocols etc., pertaining to Quality Assurance department, in line with Global GMP compliance regulations and industry practices related to Biopharma industry. 3. To ensure all time readiness for customer and regulatory audits and inspections. 4. To ensure the Quality Compliance of DS manufacturing, DS Warehouse and Engineering area activities. Operational: 1. Involving in all in process Quality Assurance activities which are executed at shop floor. 2. Monitoring of raw material and product Dispensing, Manufacturing activities in DS Manufacturing. 3. Collection and submission of Cleaning validation, and Process validation and hold time batch samples along with TRF. Forrnat_3_PROC_SCO_SOP_GHR_0217_SCO1325 (1.0) JOB DESCRIPTION PAGE 2 OF 3 4. To ensure the cGMP compliance in the DS Manufacturing, Warehouse and Engineering areas. 5. Review of Master BMRs/BPRs and executed BMRs/BPRs of DS Manufacturing activities. 6. Review and Execution of all Qualification / Validation activities of Equipment/utilities/facility of DS manufacturing areas, Warehouse, and Engineering. Provide support for review and execution of qualification activities at shop-floor. 7. To support cross functional teams in handling Investigations for root cause analysis in related to any reported Deviations, OOS, OOL and OOT. 8. Review of Change controls and support in closure of action items by ensuring compliance to inhouse and regulatory guidance. 9. Responsible for handling of cell banks. 10. Preparation and Review of Quality Risk Assessment Protocols and Reports. 11. Providing line clearance for manufacturing and warehouse (DS). 12. Handling of other responsibilities (As applicable) assigned by Reporting Manager and Head of the Department. Finance: 1. Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (I 2. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product. process or site. People: 1. Champion the Stelis Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. 2. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan
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