Responsibilities Ensuring that computer system validation deliverables like GXP, Software categorization, software qualifications, configuration specification, Risk assessment, negative challenging tests, backup & restore procedure, validation summary report, requirement traceability matrix and 21 CFR part 11 requirements are available for all the GxP systems  To revisit the site specific SOP’s related to IT and ITC periodically to in line with the corporate IT guidelines/current regulatory standards and to maintain the work practices is in line with the current SOP’s.  Preparation and Execution of the IT Roadmap for the site.  Facing Regulatory and customer audits and presenting the IT compliance status with the support from the respective SME.  Evaluating, reviewing the IT observations, internally, or during the audits, and supporting the respective department in identifying effective CAPA.  To perform IT supplier assessment for GAMP3, GAMP4 or GAMP5, software before procuring.  Perform adequate investigation and providing the root cause for the deviations identified during the failures/Deviations of computerized systems.  To ensure that all the computerized systems are meeting the 21 CFR part 11 and electronic signatures/records requirements.  To review and approve of all the validation/qualification documents related to computerized systems and ensuring the documents are in compliance.  To ensure that all IT related Risk assessments are made and necessary Risk mitigations are executed

ResponsibilitiesManage, calibrate, and maintain quality control instrumentation and equipment in accordance with established specifications and regulatory requirements Ensure all quality control instruments are properly calibrated, qualified, and maintained to support accurate and reliable analytical testing Identify instrumentation issues and implement preventive measures to avoid potential equipment failures impacting product quality or testing reliability Apply knowledge of instrument qualification, calibration standards, and regulatory frameworks to maintain a compliant instrumentation program Audit and monitor instrumentation performance and maintenance activities against defined internal and regulatory quality standards Support the qualification and validation of new instruments and equipment introduced into the quality control laboratory Report instrumentation deviations and equipment failures to relevant stakeholders in a timely manner Contribute to process improvement initiatives by identifying opportunities to enhance instrumentation management and calibration programs Maintain accurate and complete documentation of all instrumentation activities in compliance with GMP and GLP requirementsQualification & ExperienceBachelors Degree (BA/BS) B.E. - Required Master Degree (MS/MA) ME - Preferred Experience: 5 years or more in 5 - 8 Years

ResponsibilitiesHelps in demonstrating the operation in case of a new machine or a new pack-profile is implemented. Handling of Vendor Management System - Familiar with Protocol and report preparation. Well familiar with document and Data control and alternate vendor development related documentation as per cGMP requirement. Exposure to QMS software like TrackWise, ENSUR, SAP is preferred. Minimum Graduate / Post Graduate with Pharmacy /Chemistry, having exposure to work in Regulated OSD industry is preferred.

Qualification & ExpeirneceGraduate / Post Graduate with chemistry background, having technical background is preferred.

Responsibilities Stability Sample Management Manage stability sample withdrawal, storage, and handling as per approved stability protocols and ICH Q1A(R2). Perform sampling of stability batches at defined time-points — initial, intermediate, accelerated, long-term, photo-stability, in-use, and stress studies. Ensure proper labelling, storage conditions, and segregation of stability samples in designated stability chambers.  Stability Testing Conduct analysis of stability samples as per approved specifications and test procedures. Execute tests including Assay, Related Substances (HPLC), Dissolution profile, Content Uniformity, and physical parameters (description, hardness, friability, DT, water content) as applicable to stability study requirements. Ensure timely completion of stability testing and reporting as per stability protocol timelines. Document results in stability protocols, summary sheets, and reports.  Chamber Monitoring & Trending Monitor and record stability chamber conditions (temperature, relative humidity) as per defined frequency. Maintain stability chambers — 25°C/60% RH, 30°C/65% RH, 40°C/75% RH. Respond to chamber excursions per SOP. Participate in trending and interpretation of stability data. Ensure timely review and notification for any trending abnormalities or failures.Qualification & ExpeirneceB.Sc / M.Sc / B.Pharm Experience 1 – 3 years (OSD experience preferred).

Responsibilities Document Control Control issuance, revision, retrieval, and archival of QC documents — SOPs, STPs, specifications, logbooks, worksheets, MOA — per controlled document register. Maintain document cell registers — issuance, retrieval, archival, change history. Coordinate and ensure training of QC personnel on revised SOPs / specifications / MOA before effective dates.  Data Review & Compliance Review and verify analytical data from instruments such as HPLC, UV-Vis spectrophotometer, pH meter, KF auto-titrator, and balances — for completeness, signatures, calculations, and ALCOA+ compliance. Ensure testing is performed as per approved specifications and SOPs; flag any deviation in execution to supervisor. Verify SOP implementation and compliance across QC sections through periodic walkthroughs and document checks. Monitor GMP / GLP compliance in QC departments and follow up for corrective actions on observed gaps.  Investigation Support Support investigation of OOS, OOT, and laboratory incidents — gather raw data, chromatograms, instrument logs, and analyst notes for investigation files. Support continuous improvement initiatives in documentation and quality systems — paperless lab, e-logbook, LIMS adoption.Qualification & ExpeirneceB.Sc / M.Sc / B.Pharm Experience 1 – 3 years; (OSD experience preferred).

Responsibilities In-Process (IP) Analysis Perform real-time sampling and testing at granulation, compression, coating, and encapsulation stages. Conduct tests such as Weight Variation, Thickness, Hardness, Friability, Disintegration, LOD / Moisture content, Bulk and Tap density,. Ensure timely and accurate recording of results in BMRs / BPRs. Communicate and escalate any OOS, OOT, or deviations promptly. Maintain and calibrate IP testing equipment.  Finished Product (FP) Analysis Analyze finished dosage forms (tablets, capsules) before release. Perform tests including Assay, Related Substances (HPLC, UV), Dissolution, Uniformity of Dosage Units. Conduct physical parameter tests — Hardness, Friability, Disintegration, Weight Variation. Document all analysis in analytical worksheets and generate COAs. Ensure all analysis is as per approved SOPs and pharmacopoeia / in-house specifications. Handle and troubleshoot analytical instruments.Qualification & ExpeirneceB.Sc / M.Sc / B.Pharm Experience 1 – 3 years (OSD experience preferred).

ResponsibilitiesEnsure hardware qualification of computerized systems is completed as per approved protocols. Prepare, review, and execute qualification and validation documents for computerized systems and laboratory instruments. Perform and review software validation for new instruments in line with 21 CFR Part 11 requirements. Implement system and software validation for newly installed instruments/software. 2. Regulatory Compliance – 21 CFR Part 11 Maintain and secure 21 CFR Part 11 compliance of laboratory instruments and equipment. Ensure compliance related to ERES, audit trails, software categorization, user and role management, and data security. Act as administrative rights holder for instrument and equipment software installed at SPML Baska. 3. System Administration & IT Support Preparation, review, and approval of System Administrator procedures for QC instrument software. Perform IT?related activities as defined in instrument/equipment SOPs. Execute DTC?related activities for the IT department. Monitor EDMS form due dates and system documentation lifecycle. 4. SOPs, Documentation & QMS Review, prepare, and maintain SOPs related to: Backup of electronic data System control policies IT infrastructure and system security Preparation, review, and approval of IT?related protocols, policies, and documentation. Preparation, review, and approval of QMS documents as per internal procedures. Maintenance of Computerized System (CS) Software Inventory.Qualifiication & ExperienceBachelor’s degree in Computer Science, Information Technology, Engineering, Pharmacy, or Science Specific CertificationExperience 3-5 years of relevant experience in: IT support for pharmaceutical or regulated environments Computerized System Validation (CSV) Laboratory systems and instrument software

ResponsibilitiesEvaluate current systems and processes and create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and Global Quality Systems/ SOPs (GQSs/ GSOPs) in collaboration with relevant stakeholders in R&D. Conduct the outsourced BA/BE study audits (both healthy volunteer and patient based) which include investigator site audits, Site Selection Visits (SSVs), Trial Master Files (TMFs) audits, study documents audits (Retrospective audits), In-process audits etc. in order to identify gaps and areas of improvement for compliance to agreed study documents, applicable regulations and guidelines. Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) Qualification/ Re-qualification audits. Verify adequacy of all created & executed CAPAs, including CAPA identified as a result of audit by corporate audit department, followed by adequacy and effectiveness check of implemented CAPAs. Harmonize the QA systems and processes, wherever applicable and feasible, across the organization for in-house and outsourced BA/BE Studies.Qualifiication & ExperienceMinimum graduate / post graduate degree in basic sciences Experience Tenure: At least 14 years of experience in GCP environment of which at least 06 years’ experience must be in Quality Assurance (QA).

ResponsibilitiesReview of Product Quality Complaint Investigation Reports (Drug Products). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports (FAR), Recalls & Product Quality Complaint closure etc. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received Product Quality Complaints.Qualifiication & ExperienceB.Pharma / M.Sc (Life Sciences) Experience 13 to 15 Years