Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
Highly motivated individual and have superior skills in all areas relevant to the job
Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
Compile lot genealogy
Participate actively and approve deviation investigations, utilizing Root Cause tools to enable effective and timely closure of deviation investigations
Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA
Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
Support changeover activities and QA on Call
Provide training to new members and Participate in walkdown/ QA on Shopfloor and provide feedback to member of cross functional site team(s) on projects / issues
Superior ability to troubleshoot; able to identify process pathway and work to develop improvement in strategy site team(s) on projects/ issues
Understanding of advanced topics pertaining to cGMP
Participate in Regulatory Inspections or Customer Audits as required.
Identify process pathway and work to develop improvement in strategy
Help/Transfer and quickly assimilate to leadership role in other process areas
Assume Supervisory responsibility in absence of supervisor
Any other tasks as and when assigned by supervisor
Qualifications
Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
Relevant QA Operations background from the Biopharma environment.
Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, andlCHQ7).
Meticulous and Systematic.
Team player, with strong focus on safety, quality and timelines.
