In-Process Quality Assurance Specialist
7 hours ago
Job Title:
In-Process Quality Assurance Specialist
About the Role:
We are seeking an experienced In-Process Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.
Key Responsibilities:
- Review and approve executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
- Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
- Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.
- Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
- Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams.
- Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance.
- Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.
- Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, and review CAPA closure documentation to confirm adequacy of evidence.
- Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
- Ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements.
- Participate in virtual inspections and audits, providing requested documentation and clarifications.
- Maintain close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues.
- Provide remote guidance to manufacturing site teams through virtual meetings, calls, and written communication.
Requirements:
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in QMS tools and software.
Education and Qualifications:
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
Skills and Abilities:
You will need to have strong organizational and time management skills, as well as excellent communication and interpersonal skills. You must also be able to work effectively in a fast-paced environment and adapt to changing priorities.
-
Quality Assurance Specialist
24 hours ago
Mangalore, Karnataka, India beBeeAssurance Full time ₹ 9,00,000 - ₹ 12,00,000Quality Assurance SpecialistWe are seeking a detail-oriented professional to join our team as a Quality Assurance Specialist. This role plays a vital part in ensuring the quality of our processes and services.Key Responsibilities:Implement and maintain quality management systems, process improvement initiatives, and service delivery quality management...
-
Mangalore, Karnataka, India beBeeQualification Full time ₹ 20,00,000 - ₹ 30,00,000Job Title: Quality Assurance SpecialistGreetings from our team!We are seeking a Quality Assurance Specialist to join our organization in Mangaluru. Please find the job description below for your reference.Job Role: Quality Assurance SpecialistWork Location: Mangaluru (office-based)Education Qualification: Bachelor's/Master's degree in relevant...
-
Data Quality Assurance Specialist
4 days ago
Mangalore, Karnataka, India beBeeDataQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Data Quality Assurance Specialist">We are seeking a highly skilled Data Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the accuracy, completeness, and consistency of data across various systems.Key Responsibilities:">Develop and implement data quality assurance processes to identify and resolve data...
-
Data Quality Assurance Specialist
10 hours ago
Mangalore, Karnataka, India beBeeQuality Full time ₹ 15,00,000 - ₹ 30,00,000Job Title: Data Quality Assurance SpecialistThe position of Data Quality Assurance Specialist is a vital role that plays a critical part in ensuring the integrity and accuracy of data during a major migration initiative. This individual will be responsible for overseeing end-to-end testing of ETL pipelines and data warehouse migrations, guaranteeing seamless...
-
Senior Quality Assurance Leader
4 days ago
Mangalore, Karnataka, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Job Title: Quality Assurance SpecialistThe client is a robotics company that has developed intelligent, self-climbing robots designed to clean skyscraper windows without human assistance.As we transition from development to large-scale production, we are seeking an experienced Quality Assurance Specialist to oversee our quality control processes.
-
Software Quality Assurance Specialist
5 days ago
Mangalore, Karnataka, India beBeeSoftwareQuality Full time ₹ 15,00,000 - ₹ 20,00,000Job Title: Software Quality Assurance SpecialistWe are seeking a highly skilled software quality assurance specialist to play a pivotal role in our company's success.Key Responsibilities:Early detection of software bugs in the software development lifecycle, ensuring seamless collaboration with development teams for continuous alignmentImplementing automated...
-
Software Quality Assurance Specialist
10 hours ago
Mangalore, Karnataka, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000Job Title: Software Quality Assurance Specialist">This is a full-time role with some work-from-home flexibility, offering the opportunity to excel in software quality assurance.">Key Responsibilities:">Executing test plans and conducting manual testing to ensure high-quality software delivery.Identifying bugs and reporting them efficiently to drive...
-
Clinical Quality Assurance Specialist
3 days ago
Mangalore, Karnataka, India beBeeQuality Full time ₹ 90,00,000 - ₹ 1,20,00,000**Job Title:** Clinical Quality Assurance SpecialistWe are seeking an experienced Clinical Quality Assurance Specialist to provide day-to-day support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight.Key Responsibilities:Serve...
-
Senior Lead Quality Assurance Specialist
5 days ago
Mangalore, Karnataka, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000Lead Quality Assurance SpecialistJob Overview: We are seeking an experienced quality assurance specialist to oversee end-to-end testing efforts, focusing on mobile applications and firmware.Main Responsibilities:Quality Leadership: Develop and execute comprehensive testing strategies, ensuring seamless user experiences and functionality.Collaboration with...
-
Software Quality Assurance Specialist
5 days ago
Mangalore, Karnataka, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000Software Quality Assurance SpecialistThis position involves providing quality assurance support to the company's software development projects. The ideal candidate will have a strong understanding of software testing methodologies and be able to apply this knowledge to identify defects and improve software quality.Job Description:As a software quality...
