Sr. Executive/Manager - Development Quality Assurance

Role & responsibilities

Job description

• Thoroughly understands the SOPs and Company processes and policies.
• Provide proper guidance on quality issues to the process development team.
• Review the documents received from FR&D, AR&D etc. so that the same can be shared with authorities and customers.
• Review the process change proposals and provide guidance on change proposals.
• Prepare in-house expert reports/Quality overall summary (QOS).
• Ensure proper stage gate compliance at every stage of product development.
• Conduct internal audits properly.
• Review the developmental reports and other documents.
• Inspect quality till the exhibit batch stage.
• Ensure smooth scale up of the new product.
• Carry out proper documentations in labs as well as plants.
• Document all the procedures.
• Responsible for overall quality of organization.
• Assure quality by design, i.e. ensure robustness of product and process.
• Qualify resources and give them approvals.
• Review and approval of technology transfer documents like master formula record, scale up batch manufacturing record, batch manufacturing record, process validation protocol, hold time study protocol, batch packing record.
• Review and approval of formulation development documents like tooling specification, trade dress for new product, pantone colour shade card, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report.
• Review of Development Quality Assurance Standard operating procedures
• Review of stability study protocols & monthly balance verification.
• Number allocation for specification, method of analysis, laboratory standard testing procedure, analytical method validation protocol and report, analytical method transfer protocol and report, tooling specification, trade dress for new product, feasibility report, justification for specification, scientific study protocol and report.
• RLD Stock governance and control.
• Secondary responsibility in ensuring, tracking the execution, assessment and completion details of QMS documents such as DCRF, CCF, incidents, OOS, OOT, deviation and CAPA.
• Secondary responsibility in ensuring, tracking, preparing the execution. and completion details of schedules such as equipment qualification and re-qualification, calibration, internal audit and preventive maintenance.
• Responsibility for arranging training to new joinee and assessing. the training reports and periodic training.
• Performing other activities based on the need as assigned by Head.

Qualifications

• M. Pharm or Ph.D. in Pharmacy, / M. Sc. with minimum industrial experience of 5 to 9 years in pharmaceutical development./ M. Pharm (Quality Assurance)
• Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development and/or manufacturing activities.