QA Executive

7 months ago

Bengaluru, India Bioagile Therapeutics Pvt. Ltd Full time

**MAIN RESPONSIBILITIES**:

- Build, manage, lead and motivate an integrated, inclusive and flexible team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximised.
- Develop and implement a risk-based and flexible approach to Quality Assurance (QA), which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practice.
- Develop, implement, and maintain a Quality Management System (QMS) and take the lead in presenting it to pharmaceutical companies and other potential funders in contractual negotiations.
- Work with training and monitoring colleagues, to implement, review and maintain tracking of incidents within the trials, advising on CAPAs to be implemented and ensure completion in a timely manner.
- Ensure that Policies, Standard Operating Procedures (SOPs) and Internal Operating Procedures (IOPs) are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate.
- Determine staff SOP training requirements relating to QA and QC in view of their role and maintain oversight of training to ensure all staff members are trained on each SOP/IOP as required. This will involve close working with other senior trial staff as needed.
- Write, review and approve risk assessments for new trials and for ongoing projects, working closely with other senior trial staff as needed.
- Provide expert advice and guidance to the teams responsible for creating and managing Trial Master Files (TMFs), including undertaking regular audits of TMFs to ensure compliance with regulatory requirements.
- Lead the preparation for audits from external parties and assist in conducting the audit, coordinating the response, and following up to ensure that the CAPA plan is carried out within the specified timescales.
- Lead the preparation for regulatory inspections, working with other relevant staff and the funder to prepare the pre-inspection dossier, submit the response and ensure the closure of applicable CAPA plans.
- Establish an internal risk-based audit programe of both systems and trials, working with other teams as required (e.g. Information Governance team and senior trial managers). Plan and perform internal audits of processes and provide formal written feedback to include guidance on corrective and preventive actions (CAPA) to address any non-compliance with procedures and/or clinical trial regulations.
- Conduct external audits, eg of participating trial sites or third party service providers, to assess the quality of work, identify potential risks in vendor selection.
- Maintain an excellent working knowledge of the details of all relevant international and national regulations and guidance documents. Be forward thinking and identify, assess and distribute new information for inclusion in QMS.
- Provide QA advice based on analysis and interpretation of updates to GCP regulations to assure best clinical research practices.
- Engage in systems development and enhancement and in post-trial reviews and continuous improvement programes.
- Contribute to the development of an effective centralised statistical monitoring capability - engage in regular review of data in collaboration with other senior staff and make recommendations based on these data.
- Review core trial documents to ensure compliance with SOPs and regulatory requirements and to perform consistency and quality control checks.
- Attend quality review/oversight meetings with the Compliance/QA Manager from trial funders.
- Contribute to the creation and development of a diverse and inclusive culture across the organisation, collaborating across departments.
- Exercise cost control and manage expenditure to work within agreed operating budget.
- Undertake any other work that may be reasonably required from time to time.
- Undertake work in accordance with policies and values.

**SKILLS AND EXPERIENCE**:

- Substantial proven experience of taking a Quality Assurance leadership role within a clinical trials environment, either in academia, contract research or the pharmaceutical industry
- In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical trials research
- Proactive approach to reviewing, updating, and improving processes based on current knowledge of the regulatory requirements.
- Experience in auditing processes and procedures, including the development of plans for corrective and preventive action.
- Experience in supporting third party audits and regulatory inspections
- Experienced people manager, both direct reports and matrix management of teams.
- Experience of working with an electronic Trial Master File
- Good computer skills including Word, Excel and PowerPoint.

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