Analytical Quality Assurance Associate - Biosimilars

Job summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

Roles & Responsibilities

• Involve in Analytical data review and Approval.
• Review of batch analytical record for batches manufactured at CMO.
• Review and Approvals of analytical Method Transfer, Validation Protocol and Reports.
• Preparation, Review and Approvals of Study protocols and Reports.
• Review and Approvals of stability Protocols, Reports and related documentation generated from the stability studies of the products.
• Preparation, Review and Approvals of procedural documents such as SOPs / STPs / Specifications and ROA's pertaining to Quality control in accordance with current QA requirements.
• Analyst Qualification review and Authorization
• Instrument Calibration review and Authorization
• Assuring compliance on the QC floor through Lab round.
• Participate in QC Analytics LDM and update on Quality slides.
• Support for audit related activities as per requirement
• QC instrument Audit Trail support.
• You will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor.
• You will provide essential support to the supervisor in conducting investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT ) results, incidents, etc. by collating data and conducting interviews.
• You will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time.
• You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records.
• You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed.

Educational qualification: A B.Pharm. or Post-Graduation (Life Sciences)

Minimum work experience: 4 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development

Skills & attributes:

Technical Skills
. A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
. In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs.
. Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities.
. Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market.
. Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements.
. Ability to understand and implement organizational policies and ensuring compliance.

Behavioural skills
. Demonstrates a commitment to continuous learning.
. Strong communicating and influencing skills.
. Displays analytical and logical thinking abilities.
. Is self-motivated and takes initiative.
. Adaptability to the work environment, along with being a team player.
. Ability to go beyond boundaries, showcasing a proactive and innovative approach.