4 Lir Jobs

As a Quality Control Technician III at TAPI, you will be an integral part of the leading international supplier of active pharmaceutical ingredients (APIs). TAPI boasts the industry's broadest portfolio, which includes over 350 API products. With a rich history spanning over 80 years, we are recognized as one of the most trusted API suppliers globally, catering to 80 PERCENT of the top 50 pharmaceutical companies. At TAPI, our commitment to excellence is driven by our experience, expertise, cutting-edge technologies, and unwavering dedication to exceptional customer service. Your primary responsibilities will include maintaining 24/7 audit readiness, possessing expertise in Wet Chemistry, and being flexible to work in different shifts. You will actively participate in internal, external, and regulatory audits, ensuring full compliance with CAPA trainings. Additionally, you will be responsible for initiating and investigating LIR, OOS, OOT, and borderline results, promptly reporting them to the designated authority. Collaborating with various departments, you will facilitate the sharing of necessary documents from Quality Control to Regulatory Affairs and other relevant areas. In your role, you will play a crucial part in determining team priorities aligned with the plant's requirements, while coordinating effectively with team leaders and managers. Upholding stringent quality standards, you will adhere to housekeeping practices, cGMP, GLP, and Safety Guidelines within the laboratory. Your duties will encompass sampling and analyzing raw materials, finished goods, intermediates, and cleaning samples as per specific requirements, meticulously documenting results in analytical sheets, QA forms, LIMS, and online systems to ensure data integrity. Furthermore, you will conduct analytical tests following established monographs and SOPs, oversee the calibration and verification of instruments, and manage the reserved samples room along with chambers, autoclaves, and incubators. Your support will also be essential in preparing department-related documents such as STPs, SOPs, and more. Ensuring the timely sampling, approval, and rejection of labels for various products and maintaining accurate stock records of chemicals will be among your key responsibilities. To excel in this role, you should hold a Bachelor's or Master's degree in Chemistry and possess a minimum of 3 years of relevant experience in a similar capacity. Your dedication to upholding Teva's Equal Employment Opportunity commitment, which includes supporting diversity and providing equal opportunities to individuals with disabilities and veterans, is paramount in our inclusive work environment.,

Role & responsibilities Should be able to prepare PPAP documentation, PFMEA, Control plan, SPC, MSA Conduct Product LIR, inspection, process validation, Line/Process Audit Represents Internal & External (Customer) audits Operator certification Line rejection monitoring and controlling RCA for process rejection Key Skills Should have hands on experience & process knowledge of Electric machine (Magneto) Process Quality Assurance Team building & management skills Knowledge of ISO / IATF and QMS Should be proficient with MS Office Leadership skills, Interpersonal skills, Soft Skills, Professionalism Knowledge, Poka-Yoke, Kaizen, 7 QC tools, 8D, Why-Why analysis, Quality documentation Knowledge of Electrical & Mechanical assemblies Knowledge of Measuring instrument & handling Customer specific requirements review & implementation ability Able to identify potential risks within QA & plan for risk mitigation Understanding the needs & expectations of stakeholders Soft Skills Good written and verbal communication skills. Ability to work with a cross-functional team. Sense of ownership and urgency when working in the company. Strong sense of ethics Information on Selection Process: The selection process will include an aptitude test & technical test plus interviews There will be a focus on evaluation of the candidates understanding of technical, analytical & logical skills

Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc. Responsible for review and approval of all continual improvement projects affecting quality at a site Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. Development and monitoring of corrective action plans where needed Ensuring quality support to regulatory affairs as it relates to updates/changes to market authorizations Review of all documentation (i.e. LIR, OOS, Change Controls, etc.) Ensuring quality interface with internal and external customers when dealing with activities such as service requests, issue resolution, complaints, product information, or for movement of materials, products, or process from site to site Responsible for management of regulatory authority and other external compliance audits (e.g. Customer audits) including communication, tracking and resolution of observations. Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies Responsible for Performing, reporting of observations and verification of compliance reports of internal audit

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.