Positing:- Assistant Manager- Quality Assurance

Primary Location: Faridabad, Haryana

Reporting to: Quality Assurance Manager

Salary: - 10 - 20 lpa

experience in several therapeutic areas, with an extensive track record in CNS. has extensively dealt with the US FDA, EMA, DCGI and other national regulatory bodies. Has also held IND of few molecules.

JOB DESCRIPTION:

- Responsible for the maintenance and support of Quality Assurance (QA) functions spanning different departments at a regional and/or global level.

- Provide support to QA Manager with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives.

- Assist QA Manager in the quality assurance oversight of projects, assignments, training and staff. In addition to these duties, work with the Quality Department Team on other projects as assigned.

Essential Functions

- Maintaining QA function at local and/or global level along with the QA manager.

- Coordinate, develop and review SOPs in line with global best practices such that resources including time and cost are optimized.

- Provide guidance, interpretation, support, training, and key inputs to different departments/groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.

- Organize and deliver training to other departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.

- Carry out QA audits (especially database audit, Trial Master File audit etc.) as per QA plan so as to identify deviations from the applicable guidelines, regulations, protocol and agreed documents (wherever applicable).

- Oversee and participate in the documentation, reporting, and closure of compliance issues.

- Collate and analyze audit reports so as to identify systemic root causes of defects and partner with relevant stakeholders for enabling process improvements leading to deviations minimizations / amelioration.

- Review documents created in-house or received from sponsor for their compliance to the applicable guidelines, regulations and protocol (wherever applicable) and provide feedback.

- Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.

- Carry out special audits as required based on business exigencies.

- Host due diligence audits, mock regulatory inspections, and regulatory facility inspections as needed.

- Assist QA Manager with Privacy and Security Policy (special reference to GDPR) Implementation and ensuring compliance with these policies.

- Other duties as assigned from time to time.

Education and Experience

- Postgraduate / graduate degree in life sciences subject.

- 3-8 years' QA experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience.

- Experience of database audit, software validation will be preferred.

Knowledge, Skills and Abilities

- Knowledge of clinical trials and study protocols.

- Knowledge of word-processing, spreadsheet, and database applications.

- Knowledge of pharmaceutical research and development processes and regulatory environments.

- Considerable knowledge of quality assurance, quality control processes and procedures.

- Ability to work independently as well as within a team.

- Ability to maintain client confidentiality.

- Ability to manage multiple projects.

- Strong interpersonal skills.

- Excellent problem solving, risk analysis and negotiation skills.

- Skill in time management and execute workload with minimal supervision.

- Skill in developing and maintaining effective working relationships with staff.

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