Should have Extensive experience in Quality Management & Process Consulting.
Should have Experience in Reviews, Process Definition, Gap Analysis, Framework
Definition, Process Trainings.
Should have involved in establishing Quality Process frameworks.
Should have experienced in Process Frameworks like CMM; CMMi Level 3; ISO 9001: 2008 (QMS); ITIL; ISMS (ISO 27001); ITSM (ISO 20000).
Should have experienced in handling all the quality needs and audits of the organization
Should have execute global consulting engagement.
Should be able to handle client audits with ease
Should ensure the organization strictly adheres to quality in each of its process and daily work activities
Good Knowledge of Clinical Trials Domain in FDA environment
Experienced Quality professional with an expertise of handling FDA regulatory compliance related to clinical trials domain
Should have past experience in successfully helping clinical research software product companies to achieve FDA compliance for their software products.
Good Knowledge about all FDA guidelines such as 21 CFR Part 11, CDISC guidelines and other FDA regulations pertaining to clinical trials
Ability to do effective gap analysis vis–vis FDA requirements and steer the customer team to achieve the compliance successfully.
SOP development for product delivery and Product realization.
Conducting regular internal Audit for ensuring Process compliance with the regulatory standards.
Training teams internally on SOPs.
Audit facing and follow up.
Corrective and Preventive Actions on identified deviations.
Electronic Signatures and Electronic Records SOP draft and implementation.
Conducting training on SOPs.
Conducting Internal Audits.
Vendor Audits and evaluation
Salary: As per company Norms
Industry:IT-Software / Software Services
Functional Area:IT Software – Application Programming , Maintenance
Role:Quality Assurance/Quality Control Manager
CMMI Auditing Process Definition QMS ISO 9001 Vendor Audit Quality Assurance Clinical Trials Quality Management ISO 20000
Desired Candidate Profile:
UG: Any Graduate – Any Specialization, B.Tech/B.E. – Any Specialization, B.Sc – Any Specialization, B.B.A / B.M.S – Management, B.Pharma – Pharmacy
PG:Any Postgraduate – Any Specialization, MBA/PGDM – Any Specialization, M.Tech – Any Specialization, MCA – Computers, MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy, MDS – Any Specialization, Medical-MS/MD – Neuro Surgery, Any Specialization, Other
Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required
Please refer to the Job description above
ClinAsia Labs Private Limited.
ClinAsia Labs Pvt.Ltd is the closely-held affiliation of MaxisIT Inc. MaxisIT has been in business for over 13 + years serving primarily to Pharmaceutical and Life Sciences industry companies in the areas of clinical trial management, clinical data management, bio-statistics, regulatory documents and submission management and Pharmacovigilance utilizing its organically grown integrated suite of software .
ClinAsia Labs Pvt. Ltd. was established 10 + year’s back in India with an objective of building a global full service contract research organization offering integrated software platform based clinical research and allied services to global organizations, combining extreme focus on software-driven consistent Quality and built-in process level Compliance to global regulatory standard (including ICHGCP, ICMR, EMEA and FDA Standards).
ClinAsia has wide range of experience working with top pharmaceutical companies located across different geographic regions of the world on therapeutic areas of Infectious diseases, Neurology, Diabetes, Oncology, Gynecology, Endocrinology, Respiratory, Rheumatology, Dermatology, Immunology and Vaccines. ClinAsia has it’s headquarter office at India.
ClinAsia, with its globally integrated clinical research platform based services based in emerging region, brings Asian advantage and global reach to the table. ClinAsia is uniquely positioned as an electronic clinical research organization that provides full scale of clinical research and allied services to Pharma, Biotech, Medical devices companies as well as other CROs globally via its completely integrated clinical development infrastructure that is technology enabled and guarantees efficiency, consistent quality, regulatory compliance, global reach, and of course the cost arbitrage of low-cost delivery region. We are ISO 9001:2008 certified, ensuring the quality standards of Documentation and Training in the organization, ISO 27001 in terms of security and services respectively. All our products are 21 CFR Part 11 regulatory compliance and all our projects are executed as per ICH-GCP guidelines.
Recruiter Name:HR Department
Contact Company:ClinAsia Labs Private Limited
Address:H07, 4th Level, aVance Business HubPhoenix Infocity, GachibowliHyderabadHyderabad,Telangana,India 500081