Tuhit Titiya

Experience

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  Strides

  Mar 2007 - Dec 2009

  Executive qa

  in-process quality assurance (ipqa) associate. responsible for ipqa of parenteral facility. single point of contact for cleaning and process validation study. preparation and retrieving of sops and batch records. participated with the audit team of the company during the regulatory audits from usfda, mhra, tga, anvisa, who, ministry of health-ukrain. undergone on job training for cleaning validation by destin a. leblanc from cleaning validation technologies usa. at strides arco lab. bangalore. show less

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  Zydus Group

  Jan 2009 - Jul 2012

  Senior executive quality assurance

  lead in-process quality assurance (ipqa) department of parenteral manufacturing facility (lyophilized, liquid injectable in vial and ampoule). managing the workforce and work distribution of associate working in ipqa department. to support in the execution of the validation protocol, review and approval of process validation protocol/ report, and continued process verification protocol/ report, etc. responsible for final batch release for distribution from parenteral and nasal drop manufacturing facility. approver of quality management documents like deviation, capa plan, change control and product documents like mfr, bhr, process validation. participated with the audit team of the company during the regulatory audits from usfda. show less

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  Cipla

  Jul 2012 - Sept 2013

  Management associate (internal quality auditor)

  conducting internal audits of manufacturing plants of various dosage forms like injectable, oral solid dosage, topical, nasal spray / inhalers. preparation of internal audit reports and coordinate with various sites to initiate the capa / closure of the findings as per the cgmp requirement. closure of the audit report and responsible for post implementation check / compliance check at site. conducting gap assessment as per latest regulatory guidelines, warning letters and perform the risk assessment for identified gaps. lead for harmonization of validation procedures and other working procedures throughout all units of cipla ltd. participating in regulatory audit (mhra) and customer from europe. show less

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  Novartis

  Sept 2013 - Apr 2016

  Assistant manager qa

  responsible for managing quality aspects within the qa and ensuring that the operational procedure is in compliance with cgmp, the quality assurance agreement, regulatory requirements the quality manual. represent operation qa and investigations during health authority inspections. lead for the establishing of global ipqa strategy in to the various stages of vaccine manufacturing, upstream and downstream. oversight of implemented ipqa activity. managing of shop floor qa and engineering qa activities at ankleshwar rabies vaccine manufacturing plant. to ensure that production adheres to gmp standards, procedures, and systems in all respects of manufacturing including storage. review of gmp documents like qra, investigations reports, qualification records and validation documents etc. to support in the execution of the validation protocol, review and approval of process validation protocol/ report, and continued process verification protocol/ report, etc. implementing group quality policies; ensuring compliance of local regulatory/eu/us/ich international guideline as applicable. to investigate complaints, deviation and oos investigation, certified qms document approver as per the group policies. ensure timely closure of capas related to health authority, global compliance, and auditing group. responsible conducting internal audits and audit of cmos of finished pharmaceuticals. single point of contact for qms activity at site. certified lead investigator and qa approver for all qms document (qrm, deviation, capa, change control and complaints). administrator and coordinator for qms software (trackwise). show less

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  GSK

  Apr 2016 - Oct 2016

  Assistant manager quality assurance

  responsible for managing quality aspects within the qa and ensuring that the operational procedure is in compliance with cgmp, the quality assurance agreement, regulatory requirements the quality manual. represent operation qa and investigations during health authority inspections. lead for the establishing of global ipqa strategy in to the various stages of vaccine manufacturing, upstream and downstream. oversight of implemented ipqa activity. managing of shop floor qa and engineering qa activities at ankleshwar rabies vaccine manufacturing plant. to ensure that production adheres to gmp standards, procedures, and systems in all respects of manufacturing including storage. review of gmp documents like qra, investigations reports, qualification records and validation documents etc. to support in the execution of the validation protocol, review and approval of process validation protocol/ report, and continued process verification protocol/ report, etc. implementing group quality policies; ensuring compliance of local regulatory/eu/us/ich international guideline as applicable. to investigate complaints, deviation and oos investigation, certified qms document approver as per the group policies. ensure timely closure of capas related to health authority, global compliance, and auditing group. responsible conducting internal audits and audit of cmos of finished pharmaceuticals. single point of contact for qms activity at site. certified lead investigator and qa approver for all qms document (qrm, deviation, capa, change control and complaints). administrator and coordinator for qms software (trackwise). show less

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  Amneal Pharmaceuticals

  Oct 2016 - Oct 2017

  Assistant manager quality assurance

  leading quality assurance department of parenteral manufacturing facility (lyophilized, suspension, extended release nanoparticle and liquid injectable in vial /cartridge) and eye drop manufacturing facility. to ensure planning and coordination of qa-related activity in coordination with the supervisor. responsible for managing quality assurance workforce and work distribution of associate working in ipqa department. to ensure that production adheres to gmp standards, procedures, and systems in all respects of manufacturing including storage. ensure the company adherence to the required norms of local and international authorities guidelines. to conduct, coordinate/support self-inspection at site. responsible for establish quality system at new parenteral block ii. approver of quality management documents like deviation, capa plan, change control and product documents like mfr, bhr, process validation. responsible for final batch release for distribution. represent operation qa and investigations during health authority inspections. participated with the audit team of the company during the regulatory audits from usfda. show less

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  Missionpharma

  Oct 2017 - Feb 2022

  Quality auditor

  responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes as per cgmp guidelines of who, negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, gmp documentation as well as extensive communication and partnership with divisional oversight. responsible for preparation of audit report and closure of the audit report with appropriate corrective and preventive action / action taken against the findings. ensure that all the actions taken against the findings are as per the applicable guidelines. oversight for products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. obtain and maintain cutting-edge knowledge, application, and certification status for various technical/quality auditing topics. maintain awareness of evolving industry and regulatory trends/regulations. support qualification of new suppliers through pre-contract audits, issuance of findings reports, and evaluation of corrective and preventive actions. lead and coordinate with procurement and impacted site quality leads on critical audit and or audit refusals. generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed. lead initiatives / drive results in various projects like who pq of site and product, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet using site, management and regulatory. show less

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  Glocare pharma manufacturing plc

  Feb 2022 - Sept 2022

  Head of quality

  leading quality assurance department and quality control department of oral solid dosage form manufacturing facility (tablet and liquid oral preparation). team building and motivation of staff for effective and positive work culture. managing the workforce and work distribution of associate working in qa department. review of gmp documents like qra, investigations reports, qualification records and validation documents etc. ensure timely closure of capas related to health authority, ha compliance, and auditing group. responsible for establish quality system at new manufacturing block. approver of quality management documents like deviation, capa plan, change control and product documents like mfr, bhr, process validation. responsible for final batch release for distribution. to ensure that production adheres to gmp standards, procedures, and systems in all respects of manufacturing including storage. work across all disciplines (e.g. manufacturing, warehouse & qc, etc.) to ensure that the company maintains a state of all-time inspection readiness and provide support in customer /health authority inspections. to conduct, coordinate/support self-inspection at site. conduct, coordination with other departments for day-to-day activities. ensure the company adherence to the required norms of local and international authorities guidelines. to review and approve standard operating procedures related to quality, production, engineering, warehouse, and other departments. developing and implementing the quality department’s strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals. ensuring the development of departmental sops (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially. maintain confidentiality to ensure safe custody and efficient handling of company documents and materials. show less

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  Sun Pharmaceuticals

  Nov 2022 - now

  Senior quality assurance manager

  leading quality assurance department of sterile product manufacturing facility. (liquid vials, lyophilized vials, pre-filled syringes, small volume bags and sterile api). core responsibility includes building up and sustaining a successful, high performing team, coaching and development of the investigators and aseptic experts group. responsible for establish quality system at manufacturing block. responsibility for coordination and implementation of all processes around the product and release process like oox, deviations and complaints investigations, escalations, change requests. ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion. ensures that change requests, either from the production or from cross functional department, are managed appropriately from receipt, through to the implementation and closure ensure that a company quality system and standard operating procedures are in place for all cgmp/gdp related activities and that compliance with cgmp/gdp regulations is maintained through training and quality oversight. accountable for preparation of risk analysis and all relevant procedures and ensuring training of staff. support continuous optimization of the microbiological control strategy maintaining consistency with cgmp requirements. support the identification of risks and opportunities in relation to contamination control in the manufacturing environment and assist in follow-up initiatives for improvement in close collaboration with operators, qa microbiology and operations management. participation in audits performed by authorities or customers and in self-inspections. ensuring good collaboration with relevant departments (qc, stability, registration, production, ms&t etc.) as contact person for work group. show less