Date PostedMarch 29, 2023
Location (State / UT)
Experience15 Years, 20 Years
Desired QualificationBachelor Degree
Head QA – API
Roles and Responsibilities:
- Overall Responsible for Quality Assurance function and activities in coordination with all the departments and maintaining Pharmaceutical Quality System (PQS) to meet the Quality Objectives of the Organization.
- Coordinate with all the departments for hosting the Regulatory as well as customer audits, involve and ensure timely responses.
- To assist Quality Head to define individual and collective roles, responsibilities, and authorities. Active involvement in all quality-related activities to ensure compliance at Manufacturing Quality control functions and other support departments.
- To assign KRA for QA personnel, monitoring of their performances, and completion of the appraisals as directed by the organization.
- Coordinate, plan, and involve actively in Management review meetings and ensure the timely implementation of action items as applicable for an effective PQS at the site. To escalate the product, Quality, or system-related issue to site management and senior management as applicable.
- Coordinate with corporate functions like corporate quality, R&D, IT, etc. for the support required for maintaining PQS effectively. To monitor/review the performance of the PQS, and GMP activities for their continual improvement at the site.
- To identify the requirement for adequate resources and coordinate with site management & Quality Head for providing the same to maintain the effective PQS.
- To acknowledge, involve, review, and provide appropriate solutions to day-to-day troubleshooting, queries, and observations from various departments.
- Review and approve of Quality/GMP-related documents upon their satisfactory evaluation but not limited to Change controls, Incidents, Market complaints, Recalls, Vendor qualification, Investigation reports, Validation protocols & reports, JDs, BMR, SOPs, OOS, OOT, APR/PQR, various reports, CAPA, OOC, COAs, Stability study reports, Technical agreement, Specification, STPs, SMF, VMP, Equipment Qualification, Process validation, Cleaning validation, Batch release related activities, etc.
- To ensure executed BMRs/BPRs and analytical data/reports along with attachments as applicable for their completeness and correctness prior to the release of the batches.
- To review and ensure reserve sample management and Document Cell management in line with SOP for retention, withdrawal, destruction, and archival.
- To involve and or facilities for the various investigations to find the root cause and timely closure of action items derived effectiveness of CAPA.
- Ensure the internal audits at sites have been performed as per the schedule in an efficient manner by co-ordination with all the department’s HODs, auditors from CFT & site management including receipt of responses to the observation in a timely manner. Wherever possible involved in performing the same.
- To facilitate/guide and support for timely execution of various validation/qualification activities at sites. To ensure the batch release is done after satisfactory evolution of manufacturing & analytical record.
- To acknowledge all the complaints and to ensure timely and adequate investigation completion along with communication to customers accordingly. To ensure the closure of CAPA effectively.
- To ensure the stability study program is followed strictly and completion of the sample analysis timely in coordination with the Quality control head.
- To ensure effective review of physical and electronic raw data and records generated in the QC laboratory.
- To ensure the APR/PQR has been prepared and signed within the timelines.
- To impart technical training at sites for all the departments as and when required and ensure the training program is followed and training records are maintained.
- To involve in Quality metrics for the GMP Elements and monitor the performance for its further improvements.
- Coordinate and ensure handling as per SOP and guidelines related to market return goods, product recall, mock recall, regulatory submission/documents required for filing of annual report/variations.
- Coordinate and ensure with contract gives /contract laboratory and fulfill requirements as per responsibilities section in technical /quality /contract agreement and extend support as per requirement.
- To authorize discontinuation based on performance evaluation results and management decision of usage of production equipment and QC instrument, Stability testing, personnel in QA, Master documents, facility, and utility.
Experience: 15-20 Years