13.0 - 23.0 years

15 - 25 Lacs

Ahmednagar

Work from Office

JOB SUMMARY: To ensure on handling of documents like analytical test procedures, specifications, standard operating procedures from initiation till implementation. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To ensure sampling activities are performed as per SOP and sample integrity are maintained till analysis completion. To ensure working/reference standards are made available for analysis and timely qualification of standards within due date. To involve in investigations and to collaborate with cross function team for root cause determination and implementation of effective CAPA. To ensure safety and use of required personal protective equipments during day-to-day activities. Responsible for carrying out any other responsibilities assigned from time to time orally or in writing by HOD. To maintain and enhance quality index of the site unit data elements pertaining to QC function. Identify the training need and organize for the training to concerned group in QC to avoid event and unconfirmed OOS due to errors during analysis. ESSENTIAL JOB FUNCTIONS: To ensure stability samples are charged and analysis completed within the due date and stability chambers are monitored and maintained at respective conditions. To ensure effective analytical methodology are placed for testing. To ensure analytical method validation and analytical method transfer activities are completed and validated methods are adopted for testing. To ensure sampling activities of RM/Intermediates/Finished as per approved standard operating procedures. To ensure stability study sampling, stability study chamber monitoring and timely withdrawal and completion of analysis. To review the analytical method validation, method transfer, regulatory submission related documents, working reference standard procurements. To co-ordinate self-inspection (internal audit) and its compliances. To approve the lab event/out of specification/our of trend/our of calibration/CAPA/change control/deviation. Ensure trend of quality control errors and effective CAPA implementation. To monitor the compliance with the requirement of GMP. To participate in the management reviews of process performances, product quality and of the quality management systems and advocating continual improvement. To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. To conduct training program and ensure it effectiveness. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To follow safety & use of required personal protective equipment during day to day activities. To ensure maintenance of housekeeping at shop floor and reporting day to day activities to QC head and in absence delegate change to second line manager. To participate in laboratory internal audits, customer audits, health authority inspection. Awareness of IMS systems (ISO14001:2015 and ISO45001:2018) Travel Estimate Low Job Requirements Educational Qualification M.Sc Chemistry Experience 15+ years experience

Posted 3 weeks ago

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Computer System Validation Engineer First Time Us Pharmaceuticals India

3.0 - 5.0 years

84 - 96 Lacs

Navi Mumbai

Work from Office

JD Collaborate with cross-functional teams on equipment qualifications and IQS. Ensure IT compliance through validation processes. Develop computer system validation plans and protocols. QMS candidate shud b frm pharma industry gud communic skills. Cafeteria Office cab/shuttle Accessible workspace Health insurance Provident fund Annual bonus

Posted 1 month ago

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Assistant Manager - QA (Engineering) Hester

6.0 - 8.0 years

2 - 4 Lacs

Kadi, Ahmedabad

Work from Office

Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first

Posted 1 month ago

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Officer - Engineering Finecure Pharmaceuticals Limite

3.0 - 6.0 years

2 - 5 Lacs

Ahmedabad

Work from Office

Roles and Responsibilities Ensure compliance with regulatory requirements for instrument calibration, documentation, and qualification. Develop and implement procedures for SCADA system maintenance and troubleshooting. Collaborate with cross-functional teams to resolve issues related to PLC programming and control system integration. Provide technical support for process validation activities.

Posted 2 months ago

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