QA Specialist - Document Management System Job at Amgen (Hyderabad)

Qa Document Control Specialist

We are seeking a Document Control Specialist who will manage document control ac...

Location

United States

Salary:

85000.00 - 100000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree or relevant comparable background (e.g., biology, chemistry, pharmaceutical sciences)
Minimum of 3-5 years’ Quality Assurance (QA) experience within the biotechnology or pharmaceutical industry
1-2 years’ direct experience within Veeva Quality Vault
Working knowledge of electronic document management systems
Veeva Quality Vault required
General knowledge / experience in document control, data processing, and Computer System Validation (CSV) processes related to GXP document control and training systems
Strong attention to detail and a commitment to maintaining accuracy and compliance required
Proficiency in Microsoft Office (e.g., MS Word, MS Excel, Teams, SharePoint), Adobe Acrobat and Smartsheet
Exceptional organizational, communication, and problem-solving skills
Ability to work in a fast-paced and nimble environment with a rapidly growing organization, while handling multiple priorities and projects

Job Responsibility

Maintain document control policies, procedures, and systems in accordance with GXP regulations
Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training
Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records
Conduct regular audits (“data cleaning”) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and “system wellness.”
Maintain robust quality control measures for all GXP documents
Leverage experience with Veeva Systems to optimize document management processes and workflows
Provide guidance and training to staff on using Veeva for document control and compliance purposes
Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH)
Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance
Identify opportunities for improvements in GXP document and record control practices

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Specialist QA, Global Supply Quality

In this role you will be serving patients through internal collaboration with Am...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with 10 years of experience in manufacturing and quality management systems or a related field OR Bachelor’s degree with 12 to 13 years of experience in quality management systems or a related field
Minimum of 10 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations

Job Responsibility

Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type
Documentation review and approval including: supplier manufacturing records, investigation reports, Amgen quality records, and validation records (process & analytical)
Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles
Oversight and completion of supplier assessments and documentation to support product complaints
Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships
Review and approval of change control records for supplier changes
Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence
Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Take part in operational and quality improvement initiatives, programs, and projects
Develop solutions that are thorough, practical, and consistent with functional objectives

Fulltime

Specialist QA - Major Deviations

Let’s do this. Let’s change the world! In this vital role, you will serve as a Q...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of Manufacturing Support and/or Quality Assurance experience OR Bachelor's degree and 4 years of Manufacturing Support and/or Quality Assurance experience OR Associate's degree and 8 years of Manufacturing Support and/or Quality Assurance experience OR High school diploma / GED and 10 years of Manufacturing Support and/or Quality Assurance experience

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Serve as Quality investigation lead and decision-maker for complex Major Deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records
Demonstrate strong critical thinking skills, the ability to distinguish causal factors from root causes, and the ability to evaluate investigation quality using evidence-based decision making
Ensure that changes with potential impact to product quality are properly assessed and documented per established procedures
Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements
Ensure production records, laboratory results, and investigation documentation are complete, accurate, and compliant with cGMP standards
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to implement effective and sustainable CAPAs

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental & vision coverage
Life & disability insurance
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown

Fulltime

Senior Specialist, QA External Manufacturing

The Senior QA Specialist – External Manufacturing is responsible for ensuring qu...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related field
3–5+ years of experience in a GMP Quality Assurance role within the pharmaceutical or CHC industry
Experience in external manufacturing or supplier quality (strongly preferred)
Solid knowledge of EU/FDA GMP regulations, ICH guidelines, and quality management systems
Strong ability to review complex documentation with accuracy and attention to detail
Problem-solving skills with experience in root cause analysis
Excellent communication skills to effectively interface with internal stakeholders and external partners
Ability to manage multiple priorities and work independently with moderate supervision
Familiarity with digital quality tools and AI applications
Proficiency in English

Job Responsibility

Serve as the primary QA contact for assigned CMOs, monitoring performance through quality metrics, documentation review, and regular governance meetings
Support batch review and release activities, ensuring thorough evaluation of manufacturing and packaging records, analytical results, deviations, and associated changes
Review and manage deviations, investigations (including OOS/OOT), and CAPAs, ensuring scientific soundness, robustness, and timely closure
Assess change controls from CMOs, collaborating with cross-functional teams (Regulatory, MS&T, Supply Chain, Procurement) to ensure compliant implementation
Participate in internal audits, CMO audits, and regulatory inspection readiness activities, following up on corrective actions
Maintain and update Quality Agreements to reflect current operations and compliance requirements
Drive continuous improvement initiatives related to quality systems and external manufacturing performance
Support technology transfers, scale-ups, and new product introductions from a QA perspective
Partner with Technical Operations and MS&T to enhance processes and product quality

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

IT QA Specialist

We are hiring IT QA Specialist for our GCC client — Europe’s top retail brand. T...

Location

India , Bangalore

Salary:

Not provided

SRKay Consulting Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Information Technology, Computer Science, or related field
5+ years of experience in software or system QA testing
Minimum 4 years of hands-on experience specifically in End-to-End (E2E) Automation Testing.
Technical Stack: Proven expertise in Playwright or Selenium using JavaScript or TypeScript.
API Testing: Strong understanding of API automation (e.g., Postman, Supertest, or Playwright API testing).
DevOps & Tools: Solid experience with Git (version control) and integrating tests into CI/CD tools (e.g., Jenkins, GitLab CI, GitHub Actions).
Testing Foundations: Deep knowledge of QA methodologies, modern testing processes, and bug-tracking tools like Jira or Xray.
Education: Bachelor’s degree in Computer Science, Information Technology, or a related field.
Soft Skills: Strong analytical problem-solving skills and the ability to explain technical bugs to non-technical stakeholders
Experience validating data using SQL.

Job Responsibility

Automation Framework Development: Design, develop, and maintain automated end-to-end test suites using Playwright (preferred) or Selenium with JavaScript/TypeScript.
API Testing: Design and implement automated tests for API endpoints to ensure data integrity and system integration.
CI/CD Integration: Integrate automated test scripts into CI/CD pipelines to enable automated regression testing and "shift-left" quality practices.
Version Control: Manage test code repositories using Git, handling version comparison, branching strategies, and pull requests.
Test Strategy: Architect and execute comprehensive test plans that cover functional, integration, and regression testing across web and enterprise applications.
Defect Management: Identify, document, and track software defects to resolution using Jira
work closely with developers to troubleshoot and replicate complex issues.
Collaboration: Partner with developers and stakeholders to translate system requirements into technical automation scripts.
Reporting: Generate automated test reports and communicate quality metrics and risks to the broader project team.

Fulltime

QA Specialist I - Operations

The QA Specialist will work with other departments to ensure the quality of prod...

Location

United States , Madison

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 3-5 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
ASQ certification preferred
Exceptional organizational skills and attention to detail
Ability to make risk based decisions and resolve issues with minimal guidance
Excellent interpersonal skills and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, Excel, Access and Visio

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements
Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation

Fulltime

QA Specialist I

The QA Specialist will work with other departments to ensure the quality of prod...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific field
3-5 years of pharmaceutical or biotech industry experience
2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approval of Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participation in the management review process

Fulltime

QA Specialist I - Training

The Training Specialist contributes to the maintenance, delivery and improvement...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

2+ years of previous experience in GMP environment
Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment preferably aseptic manufacturing environment
Experience working with cross-functional teams and a results driven team player
Ability to multi-task in a dynamic environment with changing priorities
Bachelor’s Degree or equivalent related industry experience
Preference to degrees related to science, adult education or pharmaceutical processing
Basic eQMS/LMS system coordination, administration and/or data entry skills, preference to Master Control
Instructional Design knowledge, e-Learning Development capabilities and experience developing and delivering On The Job Training and assessment materials
Highly knowledgeable and skilled at pharmaceutical operations, including but not limited to: gowning, aseptic practices, formulation, fill/finish
Proficiency in MS Office including Word, Excel, Access and Visio

Job Responsibility

Support the manufacturing facilities and supporting functions for maintaining training requirements and needs by providing guidance and information on recommended training programs and providing routine customer service
Deliver On-The Job Training as deemed appropriate by management to support business needs and mentor trainees to competent and confident performance of new tasks
Develop, maintain and organize current and accurate training materials. This includes: On the Job Training, learning activities, handouts, checklists, worksheets, job aides and course evaluations and performance Qualifications
Deliver and / or facilitate instructor led training on GMP, technical skills, functional topics and others as deemed appropriate by QA Management
In conjunction with cross functional stakeholders assist with performing training needs assessment, develop courses and evaluations as assigned to support the business
Manage Training requirements, events and tasks in the eQMS (Master Control) for cross functional stakeholders. This may include training assignments for new hires or transitioned employees, new and revised documents or new programs
Determine the impact of process changes to current training materials and propose project plans to manage the updates
Assist with tracking of qualifications and training metrics by generating training reports
Writes and revises QA Standard Operating Procedures (SOP) under minimal supervision
Assists with training related actions associated with delivery of training in support of Quality Events (QEs)

Fulltime

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QA Specialist - Document Management System

Job Description

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