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 valuable 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

📌 Quality Control (Visakhapatnam)
🏢 Laurus Labs
📍 Visakhapatnam