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Title: IPQA Team Member

Date: 21 Jan 2025

Job Location: Bangalore

Job Description

Job Title: IPQA Team Member

Job Location: Bangalore

About Syngene:

Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.

Mandatory Expectations for All Roles as per Syngene Safety Guidelines:

  • Overall adherence to safe practices and procedures of oneself and the teams aligned.
  • Contributing to the development of procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
  • Driving a corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
  • Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
  • Ensuring all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team, including self.
  • Compliance with Syngene’s quality standards at all times.
  • Holding self and their teams accountable for the achievement of safety goals.
  • Governing and reviewing safety metrics from time to time.

Core Purpose of the Role: Team Member – In-Process Quality Assurance

Role Accountabilities:

  • Handling shift activities of IPQA.
  • Providing line clearance for batch manufacturing activities.
  • Review of batch manufacturing records.
  • Cell bank management.
  • Performing audit trail review of cGxP computerized systems.

Leadership Capabilities: NA

Syngene Values:

All employees will consistently demonstrate alignment with our core values:

  • Excellence
  • Integrity
  • Professionalism

Accountabilities as a Syngene Leader (Only for Leadership Hires):

  • Champion effective Environment, Occupational Health, Safety, and Sustainability (EHSS) practices for the company and oversee compliance within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
  • Foster a corporate culture that promotes an EHSS mindset as well as the highest standards of quality, integrity, and compliance.
  • Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework, setting high standards of people management, career planning, and talent retention as a priority.

Specific Requirements for This Role:

Experience:

  • 4-8 years

Skills and Capabilities:

  • Experience in DS manufacturing activities (upstream & downstream processes) of biological products (Preferably mAbs).
  • Knowledge of line clearance processes for DS manufacturing activities.
  • Understanding of audit trail verification of GxP computerized systems.
  • Familiarity with process equipment handling & operating systems.
  • Knowledge of WH activities such as material receipt, dispensing, and handling of rejected materials.
  • Basic understanding of cGMP regulations.

Education:

  • Master’s in Life Sciences / B.Tech in Biotechnology

APPLY ONLINE HERE

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Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.