92 Oot Jobs - Page 3

Selection of batches of Active Pharmaceutical Ingredients (API) for stability studies. Sampling, incubation, withdrawal, analysis of stability samples as per schedule. Review of stability schedule, protocols, summary & stability testing form. Stability study monitoring as per requirements of regulatory authorities, vendor requirements and as per ICH guidelines. Submission of Stability testing form to PRC, RA, CFT and other department as per requirement. Deviation logging, immediate action, impact assessment, investigation, root cause, remedial action and closing within stipulated time in Trackwise (QMS) software OOS, OOT, incidences and deviation PLEASE SHARE YOUR UPDATED CV ON placement@balpharma.com Thanks, Kamal

Role & responsibilities : Responsible for following activities: Handling of Change controls, Deviations, Market complaints, CAPA and other QMS Documents. Participate in investigation of Nonconformities. Participate in quality risk management and maintain its record. Preparation and review of Product Quality Review Report (APQR). To execute product recall and mock recall activities. To coordinate for management quality review meeting. Handling of internal audit activities and compliance with CAPA. Preparation and review of SOPs, SMF, Quality Manual Preferred candidate profile ERP/ QMS software system handling experience

EXECUTIVE-SALES PPC/-/1306251 Marketing Coimbatore Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 2 years ShareApply Basic Section No. Of Openings 1 Designation Grade Executive M10 Freshers/Experience Experience Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Marketing Country India State Tamil Nadu Region Coimbatore Branch Coimbatore Skills Skill Market and Competitive Analysis Minimum Qualification Any Graduate BSc MBA CERTIFICATION No data available Working Language Tamil English About The Role Candidate taken for the replacement of Mr.N.Sabariyar who is looking in market cirlce-COI02 of Cbe branch.Candiate should be minimum 2-Years experience in marketing and having good knowledge in system.

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

To ensure that all raw materials (API & excipients) are sampled, tested, and released. Key Responsibilities: 1. Sampling & Receipt 2. Testing & Analysis 3. Documentation & Release 4. Compliance & Audit Readiness 5. Instrument Handling Required Candidate profile Candidate must have experience in handling team of minimum 10 members. Candidate must have experience into routine analysis of raw material and QMS knowledge.

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Walk-In Interview Date : 22nd June 2025 (Sunday) Timing : 9.00 AM to 1.30 PM Venue : Umedica Laboratories Pvt, Ltd. Plot No 221,221/1 II Phase GIDC Nr Morarji Circle, Vapi 396195. 1. Tablet Manufacturing Department: Ability to handle process like Dispensing, Granulation, Compression, Coating, SOPs preparation, well versed with ALCOA & GDP principles. QMS Manufacturing investigation (OOS/OOT/Deviation/CAPA),Training.) Position: Officer to Sr. Executive Qualification: M.Sc. / B.Pharm / M.Pharm No. of Vacant Position: 20 Experience: 2 to 8 years To Operate Granulation lines (RMG/FBD/FBP/Roll Compactor), Automatic Compression Machine (PLC/SCADA based Cadmach & Fluid Pack), Coating (Kevin & Gansons) Position :Technical Associates (Operator) Qualification: ITI / Diploma /BSc Experience: 1 to 5 years No. of Vacant Position: 15 2. Tablet Packing Department: Should have sound knowledge in SOPs, BPR, Line Clearance, Daily formats &records, Manpower Handling GDP, GMP. Position: Officer to Executive Qualification: B.Pharm / M.Pharm / MSC No. of Vacant Position: 15 Experience: 2 to 8 years To Operate Blister Pack Machine ELMACH 3015 PDA machine/ IC 150C / WKH100 Cartonator machine/ Track and Trace machine with Temper Evident., CVC Primary & Secondary) Position: Technical Associates (Operator) Qualification: ITI / Diploma /BSC Experience: 2 to 5 years No. of Vacant Position: 15 3. Injectable Department: (Should have sound knowledge require in SVP, Aseptic Vial & Ampule filling, Washing, Autoclave & Sterilization. .) Position: Officer to Sr. Officer Qualification: B.Pharm / M.Pharm / BSC/ MSC Experience: 1 to 7 years No. of Vacant Position: 10 4 . Quality Control Department: Candidates having educational qualification of BSc/MSc with specialization in Chemistry. Organic chemistry/Analytical chemcistry with experience of 2 to 7 years in Quality control departments. Working exposure in HPLC, GC, UV Vis spectrophotometer, FTIR, Melting point, Dissolution Apparatus etc with regulatory exposure of USFDA/MHRA/EU/Brazil ANVISA/TGA/WHO audit. .) Position: Officer to Executive Qualification: B.Pharm / M.Pharm / BSC / MSC . Experience: 1 to 7 years No. of Vacant Position: 15 5. QA Department: (Should have sound knowledge in, Audit Trial, QMS , Training, SOP Preparation , IQPA Activities & Process Validation Position: Officer to Sr. Officer Qualification: B.Sc / M.Sc. / B.Pharm / M.Pharm Experience: 1 to 6 years No. of Vacant Position: 05 6. TTD Department: Preparation of plan regarding transfer of process / product from development, scale-up, manufacturing of exhibit / submission, launch to post approval phase which shall encompass the quality aspects (including risk assessment principles) and necessary regulatory requirement aspects. Co-ordination between R & D / client (product transferring unit) and all applicable stake holder departments in the plant (receiving unit) so as to ensure the smooth and effective transfer of product. Position: Officer to Sr. Officer Qualification: B.Pharma / M.Pharma Experience: 1 to 6 years. 7.Warehouse Department: (Should have sound knowledge in SAP, Handling of Qms Activity , handling of Purchase order, Purchase Requisition, GRN, RM, PM activities. Position: Officer to Sr. Officer Qualification: / B.com / M.com / B.Sc No. of Vacant Position: 02 8.Packaging Development Department: (Should have sound knowledge in Art Work & Product Design) Position: Officer to Sr. Officer Qualification: Diploma /B.E - Printing & Packaging Technology No. of Vacant Position: 02 Kindly carry below listed documents during interview. 1. Latest Passport size photo 2. Latest updated resume 3. Xerox copy of Qualification Certificates 4. Salary Slip / Appointment letter copy of current company / CTC Proof

Job Description Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Responsibilities Qualifications Bachelors degree

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA / Production / PPIC / Warehouse / TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Qualifications Bachler degree

Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Responsibilities Qualifications Bachelor's degree

Roles and Responsibilities: Conduct internal audits across multiple FMCG locations, ensuring compliance with company policies and controls. Analyze sales transactions, accounting entries, and GST records to ensure accuracy and regulatory adherence. Utilize SAP for data extraction, validation, and audit trail analysis. Prepare audit reports with detailed observations, root-cause analysis, and actionable recommendations. Collaborate with cross-functional teams to ensure timely resolution of audit findings. Key Requirements: 2–3 years of relevant audit experience in the FMCG sector. Sound understanding of sales processes, accounting standards, and GST compliance. Proficient in SAP and MS Office, especially Excel, for analytical review and reporting. Excellent communication and report-writing skills. Willing to travel extensively (10–12 days per month) for field audits across various regions.

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle.

Dear All, We are conducting Walk-In Interview on 13th June 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: AQA - 6-8 Years of experience in Analytical QA IPQA - 2-4 Years of experience in Line Clearance activities for Production, Warehouse and Dispensing of Raw Materials Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, HPLC and Dissolution instruments Microbiology - 2-3 Years of experience in Environmental monitoring, Culture media preparation and MLT testing Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100

24 7 audit readiness Exposure in Wet Chemistry & responsible to works in different shifts Perform the raw material analysis & wet lab activity by using the technique (KF, pH, KFC, UV, FTIR, SOR, Oven, Auto titrator, Polari meter & TLC) etc. Sampling of Raw material / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms Perform analytical test according to the monograph and SOP & follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory Participation in internal, external, regulatory audits & Ensure 100% participation in training s against CAPA s Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge Responsible for calibration and verification of instruments & maintaining of reserved samples room and chambers Must be ensured sampled, approved, and rejected labels timely as required & responsible to maintain the stock record of chemicals and reconciliation of standards Determining team priorities in accordance with the plant s needs, while coordinating with the team leader/Manager.

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle.

1.0 Job Responsibilities 1.1 Preparation and review of SOPs. 1.2 Handling of QMS documents- Change controls, Deviations, Incidents, OOT, CAPA and OOS. 1.3 Handling of Market Complaints, Return goods & Product recalls. 1.4 Review of RM, PM, IP and FP specifications and STPs. 1.5 Preparation and review of Calibration Certificates, COAs. 1.6 Review of Analytical Raw data. 1.7 Review of analytical method validations. 1.8 Responsible for Vendor management- Review of Vendor development documents and approval process. 1.9 Handling of regulatory inspections. 1.10 Audit compliance.

Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

Long Description 1 Exposure to perform the testing of Inprocess, Finished product, Stability and Cleaning validation samples etc. 2 Having knowledge of Analytical Instruments to perform the testing by HPLC, GC, UV, IR, KARL FISCHER etc. 3 Having Analytical testing skills to perform the MDI/DPI Products test like Assay, APSD, DDU, RS, Spray Pattern, FPM and physical testing etc. 4 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation. 5 Exposure of Stability sample management & Regulatory Audits. 6 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 7 Knowledge of GLP and Good documentation Practices. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Pharmacy Work Experience 5 to 8 years

Role & responsibilities QMS handling like change control, deviation, OOS, Investigation, CAPA, etc., QMS trending. Handling site QA documentation Issuance, distribution and archival of documents. Document storage management. Handling compliance wire, document management system software, track wise, SAP etc. Collaboration with cross functional team. Providing training Preparation of SOP, protocol, reports etc. Knowledge in overall API QA function. Internal audit experience will be added advantage. Participated in USFDA regulatory inspection and arrange necessary documents as needed on timely manner. Preferred candidate profile Looking only female candidates for this opening. Ready to relocated chennai location

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Handling of Quality management system like Market complaints, Change Control, Deviations, OOS, OOT, Incidents, CAPA, Self-Inspection, Vendor Qualification. Review and Approval BMR/BPRs, Prepare of Standard Operation Procedure, Process Validation, Hold Time Study Protocol and Reports, Annual Product Quality Review & trending, Cleaning validation. Qualification/ requalification of Equipments. Release of Finished Product, Continuous Process Verification, Trainings etc.

Role & responsibilities QMS, CAPA, OOS, OOT, CHANGECONTROL, Preferred candidate profile B.Sc / M.Sc Chemistry With relevant experience Perks and benefits