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
Apply Now
sales@sdichem.com
ADDRESS
SDI House
FP-27/1,
Off Bhayli Canal Road,
Near Aarna 48,
Vadodara – 391410
Gujarat, INDIA.
Tel : +91 – 97243 42202
+91 – 70691 12114
Fax : +91 – 265 – 2334397