Head of Quality Assurance

About the Company

Welcome to ViNS Bioproducts Ltd! Since 1997, we have been dedicated to developing life-saving antisera against snake and scorpion bites, as well as tetanus, diphtheria, and gangrene antitoxins. Additionally, we produce rabies immunoglobulins to combat this deadly disease. Our cutting-edge manufacturing facilities in Telangana, along with our 150-acre farms housing over 2,000+ equines and an advanced animal laboratory, enable us to create these essential products.

At ViNS Bioproducts Ltd, our experienced professionals operate fully automated facilities that meet international norms, production standards, and rigorous quality controls. Our facility is approved by PIC/s. We proudly supply our products to over 110 countries across Asia, Africa, the Middle East, Europe, Australia, North America, and South America. Furthermore, we collaborate with esteemed international organizations such as WHO, UNICEF, UNDP, and PAHO to ensure the widespread distribution of our life-saving solutions.

About the Role

To lead and manage the strategic and operational performance of the quality department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPls) and objectives, whilst adhering to regulatory compliance and achieving commercial success.

Responsibilities

• Responsible for implementing company quality ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity Issues
• To ensure the quality systems are maintained in compliance with corporate standards.
• To work on continuous cGMP enhancement, improvements in product/packing/quality.
• To support internal team and management for effective implementations of key cGMP initiatives undertaken by various site functions.
• To ensure implementation of CAPA's at sites.
• To ensure deviations/complaints are adequately investigated and ensure that action items and corrective or preventive actions are identified, addressed, and successfully implemented.
• To review, assess and appraise important product quality and product safety issues and field actions and track the execution.
• To provide regulatory support on issues to submission/review response related to deficiencies related to analytical testing.
• To ensure implementation of quality risk management for proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality.
• To assist internal QA team for evaluation and qualification of vendors for raw materials and packaging materials and service providers (as applicable).
• To review and approve OOS, OOT, market complaints, deviations, change control and associated impact assessment.
• To review the OMS tracker and ensure that all critical and major OMS documents are meet the requirement and are up to the mark.
• To provide decision on batch disposition.
• To coordinate with regulatory agency and qualified person.
• Responsible for effective implementation of QMS automation software like caliber Assure IQ and Docs IQ, Kiya GMP wherever applicable.
• Responsible for the review and approval of quality management system documents in software like, caliber Assure IQ and Docs IQ, Kiya GMP wherever applicable.
• To ensure review of batch documentation and release of the batches for distribution wherever applicable.
• Responsible for ensuring timely APQR approval and closure.
• To review quality agreements, applicable to site.
• To review and approve qualification, validation documents of equipment, system, software process at the site as per validation master plan.
• To ensure cGMP related trainings to personnel at site.
• To grant extension of investigation and CAPA implementation timelines based on overall evidence and facts and impact assessment.
• To review and approve reports/quality index for quality indicating parameters and compliance status of the site and to share the information with Management.
• To initiate field alert reports and recommend for batch recall, if required.
• To approve alert notification form and to coordinate with IRA or external partner and ensure alert notification(s) is/are submitted to qualified personnel or marketing authorization holder or applicable regulatory agency within defined time period.
• To notify contract giver for any kind of undesirable event which could have potential to trigger alert notification and to share required information as defined in respective technical agreement and to ensure the balance between service level agreement and compliance.
• To ensure timely submission of FAR/alert notification to concern regulatory agency for the critical events of product/process failures, deviations, complaints.
• To lead the site Quality review Meeting.
• To discuss all quality related issues to the respective CQ lead.
• To report the performance of the quality system/alert notification during management reviews and make recommendations for specific actions based upon significant events and quality I regulatory trends to management with executive responsibility.
• To escalate compliance risk to Management.
• To ensure effective implementation of action item derived from QRM.
• To report overall quality control and operational compliance status along with site key identified item for improvement plan and corrective action and to report quality initiative and achievements.
• To ensure quality alerts are escalated timely to senior management.
• Responsible to escalate outcome of any review/process/activity which is potential to FAR, recall, product/process/system issues, as per corporate quality policy, notification of quality events/alert to Management.
• To decide on product recall based on root cause identification.
• To evaluate and ensure impacted batches recalled from market.
• To conduct the site round at site and to ensure inspection readiness at site.
• To ensure periodic internal audits performed as per approved yearly audit schedule.
• To review and approve compliance report following the external (customer/regulatory) audit and corporate audit and ensure compliance as per the report.
• Responsible to fulfil the compliance to audit commitments completion rate.
• To coordinate with other CFT team members like Production, HRD, EMO, QCD, Stores etc. for compliance as per cGMP and regulatory requirements and quality policy.
• To ensure compliance to oversight observation made by shop floor quality assurance (IPQA).
• To monitor repetitive product failures, market complaints and stability failures and evaluation for re-formulation, revalidation (if required).
• To identify action items of product quality issues and quality trends.
• To ensure effective quality stage gate review process is established/in-place at site.
• Responsible for focused and sustained improvement in productivity.
• To ensure timely recruitment of resource and to place the right peoples at right place.
• To create KPI for sub-ordinates.
• To mentor and prepare second line as back up.
• To prepare the budget for quality department.
• To oversight assigned new projects are designed as per the expectations from Quality perspective and implemented as per the plan.
• To develop talent with appropriate skills and competencies.
• To implement the Quality department's strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.
• To ensure effective communication procedure is in place at site.
• To review the LPR, BMR, QC raw data, COA and its traceability for batch release in market.
• Responsible person for batch release in market.

Qualifications

• Master's degree in chemistry / pharmacy
• 25 years to 30 years of experience in Biotech (Plasma) / Pharmaceutical industry
• Must have demonstrated leadership experience in leading a QA team within the past 8 years.