Quality Control (Sr Manager/AGM/DGM) API

Job description

**Role & responsibilities** - To define the strategy for quality unit to meet the regulatory requirements and productivity. - Implementation and maintaining of ALCOA+ and data integrity in the Quality Control Department. - Working for the filing of USDMFs - Having the good knowledge on controlling the lab inventory. - Proper planning and utilization of Manpower. - Best Co-Ordination with QC Team for better quality output. - Planning and monitoring of QMS of the site for closure on time and provide the guidance for investigation of OOS, deviation and CAPA. - Meeting the company business requirements by supporting in the Quality control aspects. - Investigation and closure of market complaints, deviations, OOS in a timely manner. - Monitoring release / rejection of starting materials, packing materials, purified water, Intermediates and finished products and monitoring stability program. - Ensuring the compliance of the QC for 21 CFR part 11 requirements with respect to software control, procedural control and user management. - Periodic review and comprehensive analysis, trends (as applicable) for market complaints, OOS, deviations, incidents and CAPAs. - Coordination with cross functional team like production, Quality Assurance, stores, engineering and administration. - Evaluation and monitoring compliance for existing quality system for current regulatory updates. - To provide technical support as well as response to various customer queries. - Tracking of all audit points, suggestions, recommendations and non-compliance and ensure that agreed CAPAs are implemented effectively. - Ensuring implementation of pharmacopeial updates to comply the pharmacopeia requirement. - Providing the continuous training for the Quality control personnel as per the current requirements. - Good Knowledge on stability studies. - Evaluation and Maintaining of Reference standards and working standards for Pharmacopeial and non pharmacopeial products. - Handling of Regulatory deficiencies and provide the response on time. **Desired Candidate Profile:** - **Experience & Education:** Masters or degree in Chemistry or Pharmacy with extensive senior-level experience in pharmaceutical Quality Control laboratories. - **Regulatory Expertise:** Strong command over **ALCOA+**, **21 CFR Part 11**, data integrity compliance, and **USDMF** documentation filings. - **QMS Management:** Proven track record in leading investigations for **OOS**, deviations, **CAPA**, and resolving market complaints independently. - **Leadership Skills:** Experience in managing laboratory audits, optimizing workforce planning, and training team members to meet international regulatory standards.