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Quality Management Office Specialist
6-10 years
Pune
1 vacancy
Quality Management Office Specialist
Saama Technologies
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Position Overview:
This position aims to provide quality ma nagement, control , assurance , and compliance with the development process of Saama products and services.
The Quality Management Office Specialist works closely with marketing, product management, development, and quality management within Saama business lines to establish and ensure that Saama s products and services comply with Saama s quality system and applicable regulations.
The Quality Management Office Specialist is responsible for all tasks related to Product Technical Files and Documentation and for following established GMP/GCP/ISO-compliant quality system practices. This position will als o include tasks related to product and process improvement initiatives, from identification to project delivery via internal governance and control.
Key relationships:
Information Technology
Product Management
Research Development
Quality management organization
Business Teams
Operations
What We Value
Integrity: doing the right thing
Solutions: solving core, complex business challenges
Collaboration: working as one team
Innovation: changing the game
Transparency: communicating openly
Enjoy Celebrate: having fun
Key Responsibilities:
Ensures compliance with regulations (e.g., FDA, GDPR) and ICH guidelines regarding product and process development, implementation, and CAPA/Complaint Management.
Supports Design Assurance Engineer/Product Quality Engineer to ensure compliance and implementation of Saama s design control processes in assigned projects.
Review development and technical documentation related to product development during the design phase; consider current standards and regulations to ensure that design and development outputs have been completed before becoming a final product.
Participates in Risk Management throughout the product life cycle, incl. production and post-release.
Contributes to review of product and service information and marketing material
Supervises and directs quality assurance activities in receiving inspection, production, and process control and final inspection, incl. decisions upon quality-related measures before the release of products and control execution of corrective measures.
Organizes and defines all necessary inspections and testing techniques for the products in relationship with change management, complaint issues, final inspection, and production engineering.
Performs quality checks on design control, production, and study-related documentation.
Supports Validation activities to ensure they fulfill intended use.
Supports Verification and Validation activities and resolves open issues.
Supports revision of procedures, policies, and work instructions to ensure compliance with local and international regulations. Decide on Deviations and Non-Conformity Activities.
Provide quality and compliance expertise to assigned projects throughout the life cycle.
Perform and support project-specific internal and external audit activities to ensure compliance with Saama s QMS.
Provide Training to departments on quality and compliance processes.
Secondary Responsibilities
Provides assistance in all aspects of audits/audit conduct and QMS activities.
Ensure company efforts (e.g., Design Control, FMEA, Risk Change Management) comply with regulations and external standards.
Tracks and/or trends audit issues and/or CAPAs until closure.
Provides root cause guidance to CAPA owners and/or conducts root cause analysis when assigned.
Champions timely management of quality event reports, audit findings, and CAPAs.
Follows up and verifies effectiveness checks.
Reports metrics to her/his manager and Saama management as required.
Ability to work with all Saama personnel and external personnel professionally and organizationally.
Identifies and implements process improvements, focusing on the audit program.
Provides assistance in all audit/inspection types (e.g., internal, external, vendor, regulatory inspections, etc.)
Support the tracking and trending of all compliance reports and audit activities.
Communicating effectively, verbally and in writing, with all internal and external clients
Escalating quality concerns and problems to the Quality Management Office Manager or designee(s)
Working directly with Saama development teams to ensure the accuracy and consistency of system development and validation deliverables.
Supporting/conducting/leading external (vendor/supplier) quality audits and hosts/leads Sponsor/customer audits
Facilitate quality training of peers on quality-related matters
Requirements
Education:
Technical Education (Bachelors degree or equivalent) in computer sciences, health/life sciences, or equivalent is required, as is relevant work experience in a product development environment.
Experience:
Preferred at minimum 6 years of experience with Design Controls (e.g., Computer System Validation) and Quality Management systems (21 CFR Part 820, ISO 9001, ISO 13485) in a regulated environment.
Preferred at least 5 years working in cGMP and/or GCP-regulated environments.
Preferred working experience in ISO and/or GCP-related risk management activities and risk mitigation strategies
Basic auditor experience in a GCP/GMP environment is a plus.
Knowledge of and ability to apply GAMP5 and CSA guidelines
Good troubleshooting and communication skills
Good command of English. Additional language skills are preferred.
Experience managing CAPAs and complaints.
Excellent skills in analyzing issues and processes.
Team-oriented with excellent communication and organizational skills.
Strong interpersonal and communication skills, both verbal and written
Goal oriented
Detail oriented
Ability to make sound judgments
Superior problem-solving skills
Ability to manage multiple tasks effectively efficiently
Work Environment
Remote
Travel less than 20% to an office environment
Physical Demands
This position requires frequent and repetitive use of a computer, keyboard, mouse, and hand and finger dexterity.
Other Duties
Contributes to team effort by
Exploring new opportunities to add value to organization and departmental processes.
Support other departments in processing change requests, CAPA, and complaints.
Maintain the status of documents in design projects.
Support article introduction during development projects.
Communicate the status of Changes, CAPAs, and Complaints to other departments.
Adapt Quality Processes to changes in RD and Production Processes if necessary.
Knowledge of all quality core processes
Maintains Professional and Technical Knowledge by
Attending and participating in applicable company-sponsored training
Attending educational workshops and reviewing professional publications
Benchmarking state-of-the-art practices
Participating in professional societies
Keeping informed of changes in the regulatory environment and/or regulatory requirements
Please note that this job description is not designed to cover or contain a comprehensive listing of the activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.
EEO
Saama Technologies, LLC. provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all employment terms and conditions , including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Employment Type: Full Time, Permanent
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6%
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What people at Saama Technologies are saying
What Saama Technologies employees are saying about work life
based on 314 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Saama Technologies Benefits
Submitted by Company
Vacation and time-off policies Health, vision, dental, and life insurance 5- and 10-year length of service rewards
Submitted by Employees
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RGIP, Phase - 1, Hinjewadi, Pune - 411057
Pune, Maharashtra
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