Sr. QA Manager

Roles and Responsibilities
  • Ensuring Quality of products as per specification.
  • Approval of SOPs for all mfg. process.
  • Validation (as per ICH) of process, analytical methods, machines, air handling units, water, utility, cleaning processes. Mater validation plan. Revalidation in case of any changes
  • Risk analysis of process, method of all department.
  • Ensuring quality standards for all incoming material inspection like RM, PM, water, air, steam etc. pre-dispatch inspection and online inspection.
  • Internal Auditing of all departments as per schedule.
  • Handling customer, FDA, WHO, GMP, third party and Vendor Audit or any other audit.
  • Ensure implementation of all ‘’SOP’’ with co – ordination with concern dept.
  • Customer co – ordination and handling customer complaint.
  • Responsible for corrective and preventive action for customer complaint & other non-compliances, deviations and out of specification(oos). Root cause analysis of above.
  • Review and approve Calibration & validation of all measuring instruments & equipment/machines.
  • Prepare annual product review and statistical trend analysis for the data.
  • Informing any Non confirming of product/process to Management.
  • Review and approve of (BMR) Batch manufacturing records, Protocol for new products or review products.
  • Batch card issue & release and final product release.
  • Reduce W.I.P Stocks goods in the shop floor.
  • Ensuring that there is no (NC) noncompliance in any audits.
  • Training to Employee for on job training SOPs and Quality management system, GMPs, WHO standards.
  • Documentation of all Quality records.
  • Ensure & monitor for House Keeping of plant and Inter. Dept. discipline (GMP)
  • Evaluating and approving change control for the specification and test method & Mfg. Process.
  • Review of water systems and trending.
  • Control of all documents like batch cards, MFR, BMR, and all related documents.
  • Preparation and maintenance of FDA related documents, product permission and certificates.
  • To represent company in FDA for all necessary compliances related work or public communication.
  • Carry out vendor audit as and when required.
  • To check finished good products in BSR before dispatch.
  • Calculation and verification of active raw material before manufacturing.
  • Ensure & approve Online updating of BMR/ logbooks.
  • Proper storage and retrieval of BMRs and other regulatory documents.
  • Ensuring EHS standards to your working place.
  • Responsible for co-ordination to customer regulatory, documentary requirements.
  • Organize and implement product inspection as per plans in QA department. (In-coming inspection and vendor site inspection)
  • Participation in safety committee meeting regularly.
  • Maintaining discipline in department.
Skills:
  • roven experience as a quality assurance manager or relevant role
  • Sound knowledge of quality assurance, outcomes measurement processes and methodologies
  • Excellent analytical and forecasting skills
  • Demonstrated capabilities in respect to data management, statistical reports and trend analysis and professional report preparation
  • Strong planning, coordination, and time management skills to effectively support regularly scheduled and targeted audit, program evaluation and service planning
  • Excellent writing skills to document, report and communicate findings
  • Having experience of GMP & CGMP Audits
  • Thorough knowledge of methodologies of quality assurance and standards.
  • Excellent numerical skills and understanding of data analysis/statistical methods.
  • Good knowledge of MS Office and databases.
  • Outstanding communication skills.
  • Great attention to detail and a result driven approach.
  • Excellent organizational and leadership abilities.
  • Reliable and Trustworthy.
  • Experience in SAP system
Other Generic Skills:
  • Excellent technical (QA) skills
  • Problem-solving skills
  • Team working skills
  • IT skills

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sales@sdichem.com

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4, Impala House
36 Vishwas Colony, Alkapuri,
Baroda – 390 007
Gujarat, INDIA

Tel : +91 – 97243 42202

+91 – 70691 12114

Fax : +91 – 265 – 2334397

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