Job Description

Job Title: Quality Assurance (QA) Associate - CAPA, Audits & Inspections

Role detailed classification

QA Associate - CAPA, Audits & Inspections

Job Summary: 

We are seeking highly skilled and experienced Life Sciences (LS) Quality Assurance (QA) Associate - CAPA, Audits & Inspections to join our LS Practice team. The QA Associate plays a critical role in maintaining compliance and continuous improvement within GMP-regulated environments. This position focuses on managing Corrective and Preventive Actions (CAPA), supporting internal and external audits, and ensuring readiness for regulatory inspections, ensuring that documentation and processes comply with regulatory standards such as GMP, ISO, and ICH guidelines. This role is pivotal in maintaining audit readiness and driving continuous improvement across quality systems. The role will involve knowledge of cGMP, GLP and Global Regulatory Affairs guidelines, platforms and systems to undertake various assigned roles and responsibilities, included but not limited to below-described activities.

Key Responsibilities:

Life Sciences QA Associate - plays a crucial role in ensuring compliance within the pharmaceutical, medical devices and biotechnology industries by managing the assigned QA activities for ensuring compliance & ATR - All Time Readiness for Regulatory and System Internal & external audits. This role involves preparing, entering and reviewing Quality information, maintaining compliance with global standards and regulations, and utilizing QA systems to track and organize critical data for various assigned activities.

Specific activities

1. CAPA Management

- Initiate, track, and close CAPA records in alignment with quality goals

- Perform root cause analysis using tools like 5 Whys, Fishbone, or Six Sigma

- Collaborate with cross-functional teams to define effective corrective actions

- Monitor CAPA trends and generate periodic reports for management

- Ensure timely implementation and documentation of CAPA activities

2. Audits & Inspections

- Prepare and support internal audits and external regulatory inspections (FDA, EMA, ISO)

- Conduct audit readiness assessments and gap analyses

- Host client audits and respond to audit findings

- Maintain audit schedules and documentation

- Assist in vendor qualification audits and compliance reviews

3. Quality Systems Support

- Maintain audit trails and compliance tracking systems

- Support training programs related to CAPA and audit procedures

- Contribute to continuous improvement initiatives and QMS enhancements

- Ensure version control and accessibility of documents in electronic systems (e.g., Veeva, MasterControl)

- Support internal and external audits by preparing documentation and tracking findings

- Collaborate with cross-functional teams to ensure timely updates and implementation of quality procedures

- Monitor QMS performance metrics and generate reports for management

- Identify gaps in documentation and recommend improvements

- Train staff on QMS procedures and documentation best practices

4. Quality Management System (QMS): Utilizing the assigned system(s) to manage and maintain information, track submissions, health authority correspondence, and approvals across regions and functions. Support data migration, configuration, validation, and user acceptance testing (UAT).

5. Collaborate with cross-functional teams (Regulatory Affairs, CMC, Clinical, Safety) to gather and validate submission-related information for CAPA and Audits

6. Generate reports and dashboards for compliance, tracking, and data quality metrics

7. Assist in audits and inspections by ensuring traceability and readiness of Quality records

8. Participate in system upgrades and validation activities, including testing and documentation

General responsibilities

1. Compliance and Standards: Ensuring adherence to global regulatory guidelines such as ICH, ICH-GCP, GMP and managing QMS and maintenance across products/ sites.

2. Cross-functional Collaboration: Working with various client teams (e.g., RA, manufacturing etc.) to ensure timely and accurate information and ongoing compliance. Monitor changes and ensure QA system compliance. Support audits and inspections by Notified Bodies and regulatory agencies by maintaining accurate records and submission history

Qualifications & experience:

- Graduate/ Postgraduate degree in Pharmacy/ Life Sciences, or a related field.

- 4-6 years in LS QA CAPA, Audits & Inspections

- Knowledge of and Proficiency in QMS platforms (e.g., Veeva QMS, MasterControl, Track-wise etc.) and electronic document management systems (EDMS) is mandatory.

- Good to have knowledge of eCTD, Lorenz, GlobalSubmit etc. Proven experience in requirement gathering, documentation, and stakeholder management, Familiarity with eCTD, IDMP, XEVMPD, and GxP compliance, Experience with CSV/validation support is a plus.

- Good knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA & Global Health authority regulations).

- Excellent communication, collaboration, presentation and stakeholder management skills.

- Strong analytical, attention to detail and problem-solving abilities.

- Stable track record in LS Quality Assurance domain in a Mid-large Organisation.

- Proficiency in MS Office, Regulatory work processes and good knowledge of Global Regulatory submission requirements especially USFDA, MHRA, EMA, APAC, GCC, LatAm for Medical Devices and/or Medicinal/ Biotech products.

- Skills: CAPA, Audit & Inspections, QMS Platforms, eCTD, Lorenz, Globalsummit

Must-Haves:

- Skills: CAPA, Audit & Inspections, QMS Platforms, eCTD, Lorenz, Globalsummit

- Notice period - 0 to 15days only

- Job stability is mandatory