Total 3 Quality Assurance / Control job vacancies in Hyderabad

Role Summary/Purpose

Responsible for programing a component, feature and or feature set. Works independently and contributes to the immediate team and to other teams across business. Contributes to design discussions.

Essential Responsibilities

• Skilled in breaking down problems, documenting problem statements and estimating efforts.
• Ability to take ownership of small and medium sized tasks and deliver while mentoring and helping team members.
• Has the ability to analyze impact of technology choices.
• Demonstrates awareness or product positioning and key differentiation.
• Expert in writing test cases and automate them that meets standards and delivers desired functionality using the technology selected for the project.
• Demonstrates the initiative to explore alternate technology and approaches to solving problems.
• Promotes transparency by proactively sharing test design choices with appropriate audiences, with the appropriate level of detail and timeliness.
• Demonstrates expert understanding of functional and nonfunctional requirements and their priority within the backlog.

We are seeking a detail-oriented and analytical Quality Control Associate to join our team in Hyderabad, India. In this role, you will be responsible for ensuring that our products meet the highest quality standards through rigorous testing, inspection, and data analysis.

• To Plan and execute SDS-PAGE, Western Blot, Dot Blot, IEF, assays for batch release and stability with in defined TAT.
• To Plan and execute HCD, Mycoplasma(RT-PCR) assays for batch release and stability with in defined TAT.
• To Plan and execute ELISA techniques like HCP and Pro A ELISA assays for batch release and stability with in defined TAT.
• To Plan and execute CE-SDS and CZE assays for batch release and stability with in defined TAT.
• To plan and execute Physicochemical, Biochemical assays for batch release and stability with in defined TAT
• To comply and maintain the laboratory with cGMP practices.
• To adhere and follow the safety practices and procedure as per SHE.
• To report Laboratory failures, Deviations, OOS, OOT upon observation and address the same through proper investigation.
• Maintain accurate and up-to-date quality control documentation and records
• Collaborate with cross-functional teams to implement and improve quality control processes
• Monitor and ensure compliance with industry standards, regulations, and company policies
• Participate in continuous improvement initiatives to enhance product quality and efficiency
• Calibrate and maintain quality control equipment to ensure accuracy in testing
• Assist in developing and updating quality control procedures and protocols
• Train and guide team members on quality control best practices and procedures

Job Summary 

We are seeking a Quality Assurance Associate for Microbiology for managing daily Environmental monitoring operations in the Manufacturing facility as well as in microbiology laboratory. The qualified individual shall ensure that cleanrooms and classified manufacturing environments meet microbial and particulate cleanliness standards through the design, execution, and oversight of the Environmental Monitoring (EM) Program. This role supports cGMP compliance by providing data on environmental conditions by proactively identifying the contamination risks.

Roles & Responsibilities

• Routine Monitoring Activities

• You will be responsible to perform Viable (Settle plates, Active Air sampling, surface monitoring, contact plates and swab sampling) and non-viable particulate monitoring as per approved SOPs. 

• You will be responsible to perform Environmental Monitoring through LIMS software.

• Monitor different cleanroom areas including ISO5/Grade A, Grade B, C and D.

• You will be responsible to perform utilities monitoring (Compressed air, Nitrogen, CO2 and O2) for viable and Non-viable particulate load.

• You will be responsible for personnel monitoring as well as gowning qualification of personnel who will be proposed to work in cleanrooms.

• You will be responsible to perform water sampling (Raw water, treated water, Purified water, WFI and Pure steam) and to support the cross-functional department in area qualification /requalification.

• You will be responsible to maintain and calibrate EM equipment (e.g. particle counters, air samplers) and related required accessories.

• You will be responsible to train and qualify newly joined personnel in EM program and water sampling activity.

• Data Management & Trending

• Record and Review EM data accurately and in a timely manner.

• Perform routine trend analysis of viable/non-viable data and report anomalies.

• Participate in alert and action level excursions and support deviation management.

• Prepare the Annual summary report for EM program along with determination of Alert and Action level based on the historical data.

• Compliance and Documentation:

• Adhere to cGMP, GDP and internal SOP requirements.

• Prepare and review EM protocols, SOPs and investigation/ study reports.

• Support in regulatory and internal audits by providing EM data and justifications/rationale for EM and water sampling plans.

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