Senior Manager QA Biologics | Syngene | Bangalore

Job Description

Core Purpose of the Role:

Coordinating with other functions like Biologics Manufacturing, Corporate Quality Assurance, Internal Audits & Continuous Improvements, Discovery & Development QA, and various other GxP functions for the implementation of Quality Management System (QMS).

The mandatory expectation 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.
• Ensure 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
• Hold self and their teams accountable for the achievement of safety goals (only for leadership)
• Govern and Review safety metrics from time to time (only for leadership)

Role Accountabilities

• Planning and scheduling of Biologics QA Activities
• Review, and preparation of Quality Matrix, weekly and monthly reports for periodic department/ management review meetings.
• Review and Approval of General Quality Systems documents.
• Review and approval of manufacturing documents (Batch and Packaging Records, procedures, Specifications, analytical methods, technology transfer documents) pertaining to Biologic function.
• Participation and approvals of facility, process, and analytical risk assessments.
• Release of GMP Batches for dispatch post BMR review and approval.
• Create and implement QMS Metrics within Biologics.
• Liase with customers/ client/ Cross functional teams in the weekly PRMs/ Client telecons.
  Facilitate continuous improvement via QMS to improve the health of the Quality Systems.
• Lead and facilitate the client and regulatory audits for the Biologics business unit.
• Receive the audit reports and communication to the respective stakeholders.
• Lead and coordinate the writing of audit responses with all cross-functional teams within the stipulated timeline.
• Liaise with and support the Internal Audit and Continuous Improvement team for the timely closure of the CAPA.
• Review of Qualification and Validation documents of Biologics for compliance against GMP Standards and current industry practices.
• Internal Audits and GMP rounds.
• Review and approval of microbiology-related GMP Documents.
• Ensure that the QMS documentation such as Quality Manual, Site Master Files, SOPs, Validation Master Plan and Quality Agreements, and various other documents are designed, written, maintained, and revised as needed.
• Preparation, review, and approval of SOPs within QA, periodic review of the SOPs implemented across the functions, ensure their compliance against regulatory requirements and revise them, as necessary, to comply to these regulations.
• Ensure that change controls, OOS, deviations, incidents, and customer complaints are investigated, reviewed and CAPA implemented in accordance with QMS requirements.
• Responsible for the QMS function of the Biologics business unit.

Specific requirements for this role

Experience: 12 – 15 years
Education: M. Sc

Skills and Capabilities

• Knowledge of Biologics operation of downstream and upstream processes.
• Proficiency in Pharmaceutical Quality Systems.
• Managing regulatory audits.