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9 Job openings at Onesource Specialty Pharma Limited
About Onesource Specialty Pharma Limited

OneSource Specialty Pharma Limited is a pharmaceutical company focused on providing specialty therapies and developing innovative drug formulations to enhance patient outcomes.

Manufacturing QMS (Sterile, DP & DS) - OneSource @Bangalore

Bengaluru

4 - 9 years

INR 0.5 - 0.9 Lacs P.A.

Work from Office

Full Time

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.

Associate Director-Electrical & Instrumentation

Bangalore Rural

17 - 25 years

INR 25.0 - 40.0 Lacs P.A.

Work from Office

Full Time

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.

QC-Product/GLP/Inprocess/Central Lab (Sterile)

Hyderabad, Chennai, Bengaluru

2 - 7 years

INR 3.0 - 8.0 Lacs P.A.

Work from Office

Full Time

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.

Regulatory Affairs-Sterile

Hyderabad, Chennai, Bengaluru

2 - 7 years

INR 3.0 - 8.0 Lacs P.A.

Work from Office

Full Time

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.

QC-Investigations/Central Lab-Sterile

Hyderabad, Chennai, Bengaluru

10 - 20 years

INR 10.0 - 20.0 Lacs P.A.

Work from Office

Full Time

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.

Packaging Development-Sterile

Hyderabad, Chennai, Bengaluru

2 - 7 years

INR 4.0 - 9.0 Lacs P.A.

Work from Office

Full Time

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.

AM/DM/Manager-Microbiology (Sterile)

Hyderabad, Chennai, Bengaluru

8 - 13 years

INR 10.0 - 20.0 Lacs P.A.

Work from Office

Full Time

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.

Executive/Sr.Executive -Microbiology(Sterile)

Hyderabad, Chennai, Bengaluru

2 - 7 years

INR 3.0 - 8.0 Lacs P.A.

Work from Office

Full Time

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.

Executive/Sr.Executive-Production(Sterile)

Hyderabad, Chennai, Bengaluru

2 - 7 years

INR 3.0 - 8.0 Lacs P.A.

Work from Office

Full Time

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

FIND ON MAP

Onesource Specialty Pharma Limited

Onesource Specialty Pharma Limited

Pharmaceuticals

N/A

51-200 Employees

9 Jobs

cta

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Job Titles Overview

Manufacturing QMS (Sterile, DP & DS) - OneSource @Bangalore (1)
Associate Director-Electrical & Instrumentation (1)
QC-Product/GLP/Inprocess/Central Lab (Sterile) (1)
Regulatory Affairs-Sterile (1)