02/03 Vijay Tanwani
Proprietor at Sanskruti Solutions

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Quality Assurance Manager - Genomics (6-10 yrs)

Pune Job Code: 17542

Position: Quality Assurance Manager

Reports To: Chief Operating Officer (COO)

Open Category: Male / Female both can apply.

Work Location: Pune (Nearest Railway Station - Pimpri / Kasarwadi)

Working Days: Monday - Saturday (8 Hours Schedule)

Open For: Local as well as Outstation candidates both provided they are comfortable working from Pune work location.

Brief of the role:

- We- re looking for a Quality Assurance Manager to take on a new role for building and managing the Quality Systems for our cutting edge Next Generation Sequencing (NGS) Laboratory based in Pune.

- The Quality Assurance Manager is further responsible for developing, maintaining, and monitoring quality assurance operations, quality documentation, and supporting laboratory operations in compliance with standards of College of American Pathologists (CAP), Clinical Laboratory Improvement Act (CLIA) and other Quality System Regulations (ISO 15189).

Detailed Job Responsibilities:

- Assist in development and implementation of CAP, CLIA and ISO 15189 compliant quality system.

- Review all Quality documents for regulatory compliance with CDSCO (Central Drugs Standard Control Organization), FDA (Food & Drug Administration), CLIA and CAP.

- Demonstrate strong proficiency in the application of the Corrective and Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal / external quality audits or other sources.

- Provide review and feedback on validation plans and reports.

- Ensure proper management of deviations.

- Responsible for maintaining, updating and versioning of policies and protocols.

- Ensure that record keeping are attributable, legible, contemporaneous, original and above all, accurate.

Ensure that equipments are properly maintained, cleaned and inspected on a routine basis per SOPs. Manage IQ (Installation Qualification) / OQ (Operational Qualification) activities of new equipment and oversee PM (Performance Qualification) / calibration activities.

- Responsible for ensuring that equipment standards are tested, calibrated and standardized before patient testing, and that all must be documented and approved.

- Manage creation and modification of equipment SOPs.

- Provide routine review of incident and deviation logs.

- Manage employee training files.

- Review credentials to ensure compliance.

- Manage training matrix.

Skills & Qualifications:

- Bachelor's degree in a relevant chemical, physical, or biological field from an accredited college or university.

- 6-10 years of experience in quality assurance. (Experience of QA in genomics setting will be our first preference)

- Able to deliver results on schedule in a fast-paced, dynamic environment.

- Demonstrated knowledge of CAP, CLIA and ISO 15189 standards.

- Experience in evolving and scaling Quality System processes as a company grows.

- Experience in managing Corrective and Preventative Actions (CAPA), change control, and deviation (nonconformance) systems.

- Experience in performing and facilitating root cause analysis investigations.

- Knowledge of HIPAA (The Health Insurance Portability & Accountability Act) and history of working with confidential patient information is a positive.

- Demonstrated interpersonal skills in working with teams and problem solving.

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