Current jobs related to Clinical Quality Assurance Compliance - Mumbai Maharashtra India, Maharashtra - Maxis Clinical Sciences

  • Clinical Research Associate Clinical Trials

    5 days ago

    Mumbai, Maharashtra, India Talentmate skillfied mentor Full time

    We are looking for a highly skilled and experienced Clinical Research Associate to join our team, responsible for conducting clinical trials and ensuring compliance with regulatory requirements. The ideal candidate will have a strong background in clinical research and a passion for delivering high-quality results.Roles and ResponsibilityConduct clinical...

  • Assistant Quality Assurance Manager

    4 weeks ago

    Mumbai, Maharashtra, India, Maharashtra Cafe Coffee Day Full time

    Assistant Manager – Quality Key Responsibilities and accountabilities of the Role:  Serve as the Quality Assurance (QA) in charge for the assigned region, representing and ensuring adherence to quality standards.  Conduct a minimum of 25 audits at CCD outlets, 5 audits at CDX outlets, and audits of vendors, warehouses, and cold storage facilities as...

  • Quality Assurance Executive

    2 weeks ago

    Mumbai, Maharashtra, India PP Consumer Full time

    -Packaging Material Quality Assurance-Finished Goods Quality Assurance-Documentation & Compliance-Cross-Functional Coordination-Proficiency in MS Excel / QA checklists/ERP systems preferred

  • Quality Assurance Technician

    2 weeks ago

    Mumbai, Maharashtra, India, Maharashtra Shoppers Stop Full time

    Quality Assurance Specialist is responsible to ensure that all external and internal requirements are met before our product reaches to our customers. He/she will be responsible for inspection procedures, outputs and identifying mistakes or non-conformity issues.· To carry out effective PP meetings with vendor· To carry out in-line and final inspection at...

  • Clinical Research Coordinator

    2 weeks ago

    Mumbai, Maharashtra, India Oxygen Clinical Research And Services Full time

    Responsibilities:* Ensure compliance with ICH-GCP & regulatory requirements.* Manage clinical trials from start to finish.* Design protocols, monitor sites, manage CRFs & data.

  • Quality Assurance Manager

    4 days ago

    Mumbai, Maharashtra, India Tuv Full time

    Job Description: Senior Quality Assurance (QA) Manager CivilPosition Title: Senior Quality Assurance (QA) Manager CivilLocation: Mumbai (Full-time on-site)No. of Positions: 01Role OverviewThe Senior QA Manager – Civil will oversee quality assurance activities for civil engineering components of the project. This includes ensuring compliance with quality...

  • Quality Assurance Officer

    7 days ago

    Mumbai, Maharashtra, India Sona Star Healthcare Llp Full time

    We are looking for a Quality Assurance Executive with sound knowledge of ISO standards and to ensure compliance with quality systems, regulatory requirements, and continuous improvement in processes. Required Candidate profileImplement, maintain, and monitor Quality Management Systems (QMS) in line with ISO standards .Ensure compliance with CDSCO guidelines...

  • Assistant Quality Assurance Manager

    3 weeks ago

    Mumbai, Maharashtra, India, Maharashtra mCaffeine Full time

    About the jobAbout us/Company overview:mCaffeine is India’s 1st caffeinated personal care brand with an exciting range of caffeinated products for young and aspiring millennials. We believe in confidence over all skin and body biases. Redefining age-old notions of beauty associated with colour, we never sell insecurities. We have vowed not to make fairness...

  • Retail Quality Assurance

    2 weeks ago

    Mumbai, Maharashtra, India Hunarstreet Technologies Full time

    Job Summary: We are seeking a detail-oriented and analytical CX & Store Auditor to join our team. The successful candidate will be responsible for auditing CX and store teams on customer interactions, analyzing reports, post-sales support, and adherence to company policies, industry standards, processes, customer journey, and thereby providing actionable...

  • Quality Assurance Engineer

    1 week ago

    Mumbai, Maharashtra, India HRipple Solutions Full time

    We're Hiring: Quality Engineer – ProjectsLocation:MumbaiDepartment:ProjectsReporting To:Project ManagerWe're looking for aQuality Engineerwho shares our passion for excellence and precision in execution.Role OverviewAs a Quality Engineer, you'll be responsible for driving quality assurance, control processes, and capability building across project sites...

Clinical Quality Assurance Compliance

4 weeks ago

Mumbai Maharashtra India, Maharashtra Maxis Clinical Sciences Full time

Job Title: Clinical Quality Assurance Compliance & training

Experience: 5 plus years

Location: Mumbai

Type: Full-time

Experience Level: [Senior] Manager/Senior Manager

Department: Clinical Research Department


Purpose of this Role:

This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures.

Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.  Identify and decide team member’s job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required.  Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team.  Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.  Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring – site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement.


Required & Preferred Skills: • .

5 years’ experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.  Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills.  Must have experience in handling audits & inspections of DCGI, US FDA.  Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials.  Experience of working in matrix business environments preferred.  Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.