Synthite - Head - QC & QA (12-18 yrs)
Head - QC & QA FOR Synthite Industries Limited, Kochi
- Lead and manage the strategic and operational performance of the Quality Department of Bio Ingredients division, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success.
- Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
- To ensure the efficient and effective day to day running of the department
- Provide expertise on product and process quality and compliance issues
- Assess compliance to cGMP and quality systems across the area of accountability and provide expertise and support for corrective actions, improvement and readiness for inspections
- Developing and implementing the Quality department’s strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals
- Proactively monitor sources of trends, complaints, failures, deviations and changes to identify opportunities for system, process and product improvements
- Ensuring compliance to all Quality Standards
- Acting as the main point of contact on all Quality matters, internally and externally
- Coordinate vendor audits effectively
- Preparing, reviewing and approving Technical and Quality Agreements.
- Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documented review and action.
- Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability
- Preparing and justifying the Quality department’s budget and resource requirements
- Coordinate effectively with R&D, Operations and Corporate functions
- Capability to promote Quality and Compliance, able to motivate sites and units to continuous levels of quality excellence and regulatory awareness
- People Management
- Communication Skills
- Product and process Knowledge
- High Intuitive Skills
- Analytical /instrumentation knowledge
- Decision making skills
- Customer Orientation
- Need to do planned travel for official purpose
Professional & Educational Experience required:
- Ph.D/MSc. (Analytical / Organic Chemistry) with 12 to 18 years of experience with leadership role in QA/QC of FMCG/Pharmaceutical/Specialty Chemicals industry
- At least 10 years of experience in leading a team of professionals in QA, QC & Regulatory function
- Must have faced international audits in a leading role
- In-depth / broad-based knowledge of advanced QA, QC, Regulatory, cGMP, GLP
- Should have an experience of closely working with Regulatory Affairs and quality Standards
- Publication and/or patent record is an added advantage
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