Skills:
QMS, Statutory Audits, CGMP Manufacturing, schedule m, CTD Documents, OOS, deviation investigation reports, Chemical Engineering,
Company Overview
Infinitalent Consulting (P) Ltd is the best rated HR consulting firm in India. We specialize in permanent placements and temporary staffing for various industries. With our expertise in talent acquisition, we help businesses find the right candidates to drive their growth. With over 10 years of experience, our company has become a preferred recruitment partner for many organizations.
Job Overview
We are seeking a highly experienced Senior Quality Manager to join our team at Infinitalent Consulting (P) Ltd. As the Senior Quality Manager, you will be responsible for ensuring the quality and compliance of our company's products and processes. This is a full-time position based in Bangalore Rural, Karnataka, India.
Position: Senior Manager - Quality
Reporting to : Managing Director
Work Location: Doddaballapur, Bangalore
Qualifications And Skills
- Minimum 12 to 15 years of experience in a similar role, preferably in the pharmaceutical or chemical manufacturing industry
- Strong knowledge of quality management systems and regulatory requirements
- Direct exposure to regulatory audits with examples of interactions (verbal and written) with auditors
- Good communication skills ability to write clear reports (such as OOS, deviation investigation reports)
- Teamwork Ability to work cross-functionally
- Familiarity with CGMP manufacturing processes and requirements
- Knowledge of Schedule M and CTD documents
- Ability to investigate and prepare deviation investigation reports
- Master's degree in Chemical Engineering or a related field
- Excellent communication and leadership skills
Roles And Responsibilities
- Develop and implement quality management systems (QMS) to ensure compliance with industry standards and regulations
- Lead and manage a team of quality professionals to achieve company goals and objectives
- Conduct regular audits to assess the effectiveness of quality control measures
- Prepare responses to audit observations and communications to external parties related to QMSs
- Interact with customers to satisfy their VQ requirements
- Ensure adherence to Good Manufacturing Practices (GMP) and other applicable regulations
- Interact with customers on any product quality issues
- Prepare and submit CTD documents to regulators as required
- Investigate and resolve deviations, non-conformities, and customer complaints
- Collaborate with cross-functional teams to identify areas for process improvement
- Provide training and guidance to employees on quality-related topics
- Stay updated with industry trends and developments to implement best practices
