271 Process Validation Jobs - Page 9

Role & responsibilities • You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents. • Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. • You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). • You will review and compile raw data, relevant certificates, analysis test reports and • preparation and review of final summary report. • You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation. • Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval. • You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification. • As part of your role, you will prepare and review VMP (Validation Master Plan). • You will conduct training for employees and external vendors as a qualified trainer. • Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label. • You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment. • You will also provide necessary assistance and support to various regulatory, internal and external inspections.

Role & responsibilities Preparation & review Protocol & Reports of Process validation, cleaning validation, CEHT/DEHT study and wet cake hold time study. Preparation, review and tracking of periodic evaluation of validated process. Review of Qualification documents like URS, DQ, IOQ, PQ, Requalification, Verification Qualification, temperature mapping, etc. Monitoring the validation (Process/Cleaning) activities. Verification of Analytical records, Executed Batch Production Record and Equipment Cleaning Record as a part of Process Validation and Cleaning Validation. Please share profiles with job title on gaurangikudavkar@lupin.com

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Location - Mysore Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. if interested kindly share their updated resume with below details to priyanka@avaniconsulting.com or whatsapp to 9518220852 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:

Must to have experience on new product development, technology transfer, and process validation from R&D to pilot scale and further to commercial production. Develop BFD, PFDs, and P&IDs for new products and process trials.

Role & responsibilities Aurobindo Pharma Ltd. Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Assurance (Market Complaints / QMS / Validation / IPQA) Quality Control (GMP / GC / LCMS / HPLC) 3 Experience Required: 2 7 years (pharmaceutical manufacturing) Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: Quality Assurance Key Scope • Handle Market Complaint investigations, trend analysis and regulatory responses • Maintain site QMS: Deviations, CAPA, Change Control, Audit readiness • Execute and review Equipment / Process / Cleaning Validation documentation • Perform IPQA activities: line clearance, in-process checks, batch record review • Conduct GMP & Data-Integrity training for shop-floor teams Quality Control Key Scope • Routine & stability testing of RM / IP / FP samples on HPLC, GC, LCMS, UV, etc. • Prepare/standardise analytical methods, calibration & instrument qualification (IQ/OQ/PQ) • Adhere to GDP, ALCOA+ and cGMP guidelines; ensure timely LIMS/SAP data entry • Investigate OOS/OOT results and implement effective CAPA • Support regulatory, customer and internal audits Common Requirements: • Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry or related) • Sound knowledge of current GMP guidelines (US-FDA, MHRA, EU, WHO) • Good documentation, investigation and communication skills • Willingness to work in shifts and collaborate with cross-functional teams How to Apply • Send you updated resume : naidupetahr@aurobindo.com • WhatsApp : 9851444337

KWALITY PHARMACEUTICALS LTD. 6TH, MILE STONE, VILL. NAG KALAN, MAJITHA ROAD, AMRITSAR- 143601.(INDIA) About Our Organisation : Kwality Pharmaceuticals Ltd. is a manufacturer of finished pharmaceutical formulations in a dosage form. The company was incorporated on May 4 1983, and is ever progressing in Domestic and International markets. Kwality Pharma was Incorporated on May 4th 1983 by Mr. Ramesh Arora ( Founder ) of the company . Our company is based on its commitment to high quality and timely supplies. Kwality Pharmaceuticals Ltd are leading manufacturer & exporters of pharmaceutical formulations in Liquid Orals, Powder for Oral Suspension, Tablets, Capsules, Sterile Powder for Injections, small volume injectables, Ointments, External Preparations, ORS and many more.... in various categories like Beta Lactam & non-Beta Lactam, Hormones, Cytotoxic (Oncology) and Effervescent as per new GMP norms. The company specializes in handling customized business as per the requirements. The company has registered its products in different countries of Europe, Africa, Asia, Central American, and South American Countries & CIS Countries. What we are looking for : QMS / Process validation / Method Validation Role & Responsibilities : • To review, maintain and implement change control management. • Tracking and trending of CAPA for site and its verification of CAPA effectiveness. • Handling of regulatory inspections and preparation of audit compliance reports. • To review and approval of sampling protocols, validation protocols and reports. • Responsible for review and tracking of technical agreements for the site. • To involve in Preparation, Approval, Issuance and Retrieval of Documents. • Responsible for assessment, review and tracking of vendor service agreements. • To ensure preparation and approval of Annual Product Quality Reviews. • Review of incident investigation reports and monitoring of CAPA arising from the incidents. • To Review and preparation of specification / STP • To ensure adequate and timely review, approval of incident investigations and verification of the action plans. • Review and approval of Site master file, Quality Manual and Validation Master Plan. • To ensure reserve samples of finished products are maintained as per defined SOP. • Ensure cGMP compliance at site. • Responsible for ensuring quality and compliance wherever the GMP activities performed within the department and at the site.

To Prepare, manage and review validation master plan and cleaning validation master plan. To prepare and summarize results when writing final validation. To review and coordinate for all type of third party calibration. To prepare execute protocols and report of process validation, hold time study, HVAC, Water system and collection of samples. To initiate and evaluate of change control, risk assessment of product as well as equipment. To prepare annual product review and provide data related to validation and qualification. To follow and implement current GDP and SOP during work.

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Notice Period - 1 month ( maximum) Location - Mysore ( Nanjangud) Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. if intrested kindly share their updated resume with below details to mona@avaniconsulting.com or whatsapp to 7327039030 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:

Role & responsibilities To establish the quality, health & safety policies, procedures, standards and specifications Maintain Certificate of Conformity for all our Products To work with the procurement team & production team to ensure quality standards To look at ways to reduce waste and increase efficiency; To set audit/ inspection procedures, protocol and checklist To conduct periodical inspections at the supplier location & also our warehouse for quality control, evaluate problems and suggest corrective action Focus on Continuous Improvement Preferred candidate profile Women candidate with Graduate in BSC Chemistry / B Pharma

Dear All, We are looking for as Junior Engineer - Tool & Process development for GTTC, NTTF & CIPET holders. Job Description. New child parts development (tool and process) to meet master schedule a. Tool spec review, Tool design review b. Inspection report review c. Tool Correction plan review d. Schedule review e. Handover tool and process f. Co-ordinate with CFT to get and share information related to NPD g. Develop facilities that is unique for the part ECI implementation and monitoring Adherence to IATF requirement Master list control QCPC,PCA,FMEA,SMH, gauges, fixtures, trim tools, dies, moulds, part weight, shot weight, RM details. Meet the IOC requirements given by PC Follow Safety rules Continuously improve the process by nurturing the spirit of originality, enthusiasm and innovative challenges Work in harmony within department, with other departments and vendors to solve the problems. Implement gorika. Actively participate in suggestion scheme. Interested candidates can send resume at manohara.is@trmn.biz

Vibonum Technologies, Bangalore is hring: Executive - AQA/QMS/DOC Cell Executive - IPQA/QMS Role & responsibilities Review and release the Finished products/Raw materials/ stability samples after the analysis in line with defined procedures. Review and approval of Qualification, validation documents, protocol, and reports. Initiation and / or Review and approval of QMS elements like Change controls, deviations, Out of Specifications, Out of Trends CAPA, etc. Management of Document cell (Issuance, retrieval archival and destruction of documents) to avoid any unauthorized access and usage of documents. Conduct training for newly joined Employee and existing employee and evaluate the effectiveness of the procedure. Review of batch documentation (BMRs, BPRs, COAs etc) manufactured and compilation of a complete set of batch documents required for batch release Perform the other activities assigned by the department Head. Preferred candidate profile Well-versed with OSD Manufacturing and Packing activities Sharp in Documentation and Review of shopfloor data Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any at shopfloor operations. Knowledge of the local language (Kannada) is an added advantage Perks and benefits: Best in the industry. Early joiining will first prference.

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety & quality standards. Work closely with manufacturing, R&D, and QC teams. Requirement: 2+ years of QA experience, preferably in cosmetics or pharma manufacturing. Required Candidate profile Skincare manufacturing & QC expertise Knowledge of FDA, GMP, ISO regulations Attention to detail & procedural compliance Strong analytical, problem-solving & com skills Ability to work with GMP proces

Role & responsibilities Media section prepares small and bulk volume of media to produce FMD/HS antigens and related to cell and virus/ Bacterial culture sections To update the regulatory documents online Involved in microbial upstream and primary downstream processes Coordinating with internal and external departments like QC, QA, and engineering. Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines Preferred candidate profile Should have experience in handling various bioreactors adherent and suspension cell cultures, cell passaging. Exposure to regulatory audits.

Work Experience (Total number of years/ experience/ background or equivalent) : Total experience (in years): 15 Experience in current role (in years): 6.5 Years Work Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management Primary Job Function - To drive technology transfer for Third party manufacturing, Loan license projects, Abbott s own manufacturing plants. To support Abbott site MS&T team as per requirements. To support Alternate supplier qualification of raw materials & API. To comply with the regulatory, quality, statutory, EHS and Pharmacovigilance requirements. Core Job Responsibilities - To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer. To prepare Master formula record & Technology transfer protocol for products identified for transfer. To Review receiving site s draft documents pertaining to manufacturing, process validations & analysis of product under transfer & executed documents post validation. To execute validation batches and to ensure validation batch reproducibility is demonstrated in commercial batches. To review executed process validation batch documents & support FLQR approvals. To service, trouble shoot and solve production process problems at manufacturing site. To acquire sufficient process understanding at current manufacturing site to enable effective investigations of commercial batch failure or market complaints and to contribute towards appropriate CAPA. To carry out due diligence of new sites with focus on formulation and required infrastructure and support new product acquisitions & product certifications. To work towards improving knowledge base for handling of Parenteral products in addition to the other dosage forms such as Oral solids, Oral liquids, Topicals, etc. To extend technical support and batch execution (as applicable) to activities like Alternate Supplier Qualification and Material Harmonization. To initiate, review & approve change controls in Soltraq. To author, review & approve technical documents in Darius. To extend support to NPI activities like Dossier review, Product certification & FLQR approval. To extend support to I&D for new product launches, review & approval of technical documents, batch monitoring & FLQR approval. To keep track of ongoing projects and update senior management beforehand.

Role & responsibilities Validation & Qualification of Equipment Experience in Autoclave, Terminal, Sterilizer, Mixing Vessel, Tunnel Qualification, washing machine and filling machine. HVAC Qualifications Validation and qualification protocol and report. To ensure material issuance for validations activities & keep Section Manager updated. To ensure implementation of validation, qualification activities & inform to Section Manager for any deviation from written procedure. Equipment Qualification Steam Heat Sterilizer, Terminal sterilizer, Preferred candidate profile:- Result orientated Communication skills Presentation skills Analytical skills Lateral coordination * Candidate can share their resume at anee.silas@otsukapharma.in

In Process Quality Engineer ( Snr Engr/ Engr (7-8 Yrs exp) Responsibility: In process Inspection laser, TPP, Bending, Welding, Powder coating/ Passivation ) Shall have good knowledge in welding & NDT method _ preferred CSWIP / AWS certified welding inspector Experience in sheet metal Fabrication industry with knowledge on process , Validation, Qualification & Audits. Allocation of manpower – shift plan > should be capable of handling multiple process _ laser , TPP, Bending, Welding , Powder coating & Passivation. Contribute in feasibility study along with CFT Team In New product development Instrument Calibration (Verify, Issuing to line). Handling of Customers, Audits & Supporting for the special Process Audits with all the required documents. Understanding on powder coating and passivation In process quality activities like inspection, daily qualification activities, capable in problem solving techniques, brain storming techniques. In house qualification of powder, paint and operator qualification knowledge.(added advantage) Knowledge in QMS, 5S, KAIZAN, CAPA, COPQ, PPM Trends. Knowledge in understanding of drawing notations, customer specification requirements. Knowledge in Internal audits as well customer audits and interaction with suppliers and customers.

QA Senior Executive / Quality Assurance Manager CTC UPTO 6 LPA, Contact: 09990842892 Email: info@wellgen.in We are a 30-year-old Medicine Manufacturer Company is located in Baddi Experience : Minimum 7 years of Pharmaceutical Experience Qualification : B.Pharm You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)Role & responsibilities Preferred candidate profile Male candidate

Responsible for commercial batch release to market. Responsible for in process Quality Assurance activities. Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components. Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for Sampling & compilation of Process Validation Reports (PVRs) Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Good Documentation recording and updation. Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs). Responsible for the routine GMP Inspection & review of Quality Records of other departments. Responsible for monitoring in Aseptic process simulation study. Responsible for Preparation and Compilation of Media Fill Protocol , Report. Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation. Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas Responsible for preparation and implementation of SOPs Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule. Responsible for personnel monitoring. Responsible to participate in qualification, requalification, area qualification activities. Activities other than in the Job responsibility are to be done as per requirement of HOD.

Roles and Responsibilities Develop process designs, including P&IDs, flowsheets, and equipment sizing. Conduct process simulations using Aspen Hysys, Aspen Plus, or other relevant software tools. Collaborate with cross-functional teams to optimize processes for energy efficiency and cost reduction. Perform debottlenecking studies to improve plant capacity utilization and reduce bottlenecks. Participate in scale-up activities from lab to commercial production. Preparation of Process flow (PFD) & P&ID Monitoring the Process validation batches as per cGMP Experience on Solvent recovery and re use Experience on Process time cycle reduction Equipment mapping and suitability as per the process Material and energy balance calculation Desired Candidate Profile B.Tech/B.E. degree in Chemical Engineering (or equivalent). 1-5 years of experience in chemical processing engineering with expertise in technology transfer, process validation, and scale up. Strong understanding of chemical engineering principles and practices; knowledge of thermodynamics, kinetics, mass transport phenomena etc.

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; . Strong understanding of Good Manufacturing Practices (cGMP), Current Good Laboratory Practice (cGLP), and International Organization for Standardization (ISO). Proficiency in handling chemicals safely according to OSHA regulations.

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

Position will be responsible for Maintenance and Adherence of Corporate QA function basically ISO 9001 and Quality Management System EHS standard sustenance . Key Responsibilities and Deliverables. 1. Ensure and oversee the development, implementation, and ongoing maintenance of all necessary QMS and EHS system. 2. QMS Performance: Report on the effectiveness of the QMS, identifying areas for improvement and necessary actions. 3. Promoting Customer Requirements : Ensures that customer requirements are communicated effectively throughout the organization, fostering a customer-centric culture. 4. Coordinating Internal/ External Audits: Coordinates the planning and execution of internal audits to assess the effectiveness of the QMS. 5. Facilitating Management Reviews: Facilitate management reviews, where top management assesses the QMS's performance and identifies areas for improvement. 6. Acting as a Point of Contact: Serve as a primary point of contact for external parties, such as certification bodies and customers, regarding the QMS. 7. Promoting Continual Improvement: driving continuous improvement within the QMS, ensuring that the orgn remains aligned. 8. Ensuring non-conformities are Addressed: Ensure that non-conformities are promptly identified, investigated, and addressed through appropriate corrective and preventative actions. 9. Coordinating with Product Quality Certification Body and internal team on Bureau of Indian Standards BIS, compliance of RoHS with Suppliers . 10. Ensure WT Products food grade certification Audit /sustenance and periodic audit support. 11. Ensure Global audit is well organized and achieved the intended results. 12. Support FM Global audit to ensure all system requirements are in place. 13.Coordinate and ensure that company policies, procedures, and work instructions are documented, and personnel are trained. 14.Preparing and submitting monthly management reports relating to company systems, compliance and incidents: Qualification : B E Mechanical ( 6-8 years of experience ) / Diploma Mechanical Engg with(8 to 10 years of experience) in product manufacturing company.

Seeking a dedicated QA Personnel for our Pharma Plant to ensure compliance, quality, and safety. Must have skills in Risk Management, Tools & Techniques, Training & Development, and Process Validation & Improvement. Required Candidate profile 10+ yrs in QA. Maintain QMS per GMP & regs. Review docs/SOPs, batch records. Train staff. Use automation for API, functional & performance testing to boost quality & efficiency

Position: Manager Quality (QMS) Experience: 8 to 14 years Location: Kurla, Mumbai Qualifications: B. Pharma / M. Pharma / M.Sc (Chemistry) Shift Time : 5 PM- Midnight Work Model : Hybrid (3 WFO+ 2 WFH), later can change Industry Preference: OSD and API plant Key Responsibilities & Required Experience: In-depth knowledge of Quality Control investigations including OOS, OOT, Lab Incidents, and Deviations Expertise in Root Cause Analysis and Risk Assessment Hands-on experience with analytical instruments and various QC techniques Proficient in drafting Quality Technical Agreements (QTA) Skilled in compendia assessments , data trending , Annual Product Quality Review (APQR) Exposure to Process Validation , Cleaning Validation , and Equipment Qualification 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 our sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.