Ensuring right ecosystem for Quality function
- Contribute to developing quality goals and targets in the organizations strategic plan
- Evaluate results of quality operations; prepare recommendations regarding significant changes that need to be made to the organizations manufacturing processes, system, technology, raw materials, inputs , vendor, etc
- Liaise with functional and operations managers (R&D, Manufacturing, Engineering, SCM, HR, Administration, etc) for implementing new procedures, processes or methods to improve quality and performance.
- Guide team to meet regulatory requirements in accordance to respective country/regions guidelines by designing, developing and implementing quality standards.
- Effective use of operating budgets; ensure effectiveness of quality operations
Ensuring effective operations of Quality department by effectively managing teams to:
- Monitor that quality targets and standards are met in the organization.
- Ensure implementation of Quality Risk Management system
- Liaise with external customers and regulatory authorities for effective implementation of quality and regulatory systems.
- Ensure adequacy & sufficiency of data for faster regulatory approvals
- Plan and prepare regulatory submissions for bulk actives
- Making sure that deviations are investigated and resolved.
- Reviewing and approving validation protocols and reports.
- Making sure that effective systems are used for maintaining and calibrating critical equipment.
- Making sure that materials are appropriately tested and the results are reported.
- Performing product quality reviews.
- Develop the team as quality experts who ensure quality management system implementation in letter & spirit
Handling of Audits:
- Ensure that quality related complaints/ deviations are investigated and resolved.
- Close investigation issues with appropriate Corrective Action & Preventive Action (CAPA)
- Assess, review and provide inputs towards root-cause analysis
- Guide team to build investigative skills
Ensure Good Documentation Practices (GDPs):
- Ensure internal audits are carried out as per schedule and necessary corrective active preventive action is taken.
- Host regulatory audits and provide response to queries
- Develop / train the team to interact/ face regulatory and client audits and demonstrate the GMP adherence
- Ensure anytime audit readiness
- Accurate & up-to-date technical documents in accordance with regulatory compliance
- Archival & retrieval of documents
- Prepare / review documents / reports as maybe required
- Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Optimum utilization of resources:
Maintain records, data integrity & safety:
- Plan for optimum utilization of resources (manpower, materials and infrastructure) for deliverables
Understand & adhere to safety norms
- Maintain strict data integrity and adhere to all related policies
- Ensure skill development of self & team:
- Inspire, motivate, hire, and retain right talent
- Participate in recruitment process
- Motivate, recognize and retain best talent through various reward & recognition programs
- Train and develop team members through Learning & Development programs
- Enhance team performance through periodic reviews and corrective measures
- Career management discussions with team members
- Mentor team members
- Improve employee satisfaction scores
- Continuously update self on industry trends
Education (minimum/desirable): M.Sc./M. Pharm. - Chemistry (Organic/Analytical) with Certified Lead Auditor and 15 - 20 yrs relevant experience
Desirable: PhD or equivalent.
Experience/Professional requirement: 1. Knowledge of and compliance with regulatory guidelines
2. Knowledge of quality management systems & data investigative techniques
3. Ability to prepare, review and communicate tech-nical documents
4. Knowledge of and adherence to GxP guidelines
5. Data integrity, safety & continual Improvement
6. Knowledge of Analytical Method Validation and Development
7. Good Communication skills
Salary: Not Disclosed by Recruiter
/ Clinical Research
Functional Area: Medical
Role Category: R&D
Role: Bio/Pharma Informatics-Associate/Scientist
Employment Type: Permanent Job, Full Time