Qc Head from Pharamaceutical background Only

Agio Pharmaceuticals; Pune District; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Agio Pharmaceuticals invites a seasoned QA/QC leader to take overall responsibility for Quality Control Operations in a GMP environment. You will ensure GLP compliance, data integrity per 21 CFR Part 11, and sign off on QC reports and analyses.

You will drive instrument qualification, sample storage, training, audits, CAPA, and collaboration with Regulatory and R&D for method transfer, validation, and timely release of materials.

Responsibilities

• To undertake overall responsibility of Quality Control Operations.
• To ensure quality control lab compliance with respect to GLP/21CFR part 11/data integrity.
• To verify and sign off QC reports, documents pertaining to analysis and validations.
• Ensure the samples are stored according to appropriate order to obtain the required quality.
• Monitoring and control of the analysis and documents.
• Evaluation of analytical procedure and calibrations/qualification of instruments.
• Ensure that the required initial and continuous training of quality control personnel is carried out and adopted according to need.
• To Ensure the retention of analysis records and Control samples.
• To Ensure the proper storage conditions for reference and working standards are maintained.
• Responsible for co-ordinating regulatory inspections and ensuring laboratory compliance.
• Ensure that the appropriate validations including calibration of control equipments are done as per the set frequency.
• Ensure that the employees are trained based on safety and GLP principles adopted in quality control department.
• Handling of analytical plans for timely release of raw materials & packing materials.
• To ensure the sampling instructions, test methods and other quality control procedures are available.
• Interaction and co-ordination with analytical research and development department for analytical method transfer activities.
• Co-ordinate with regulatory department for registration requirements.
• Review and approval of standard operating procedure and biological testing on drug product.
• To handle various audits as front line auditee and compliance of the NCs raised in the audits.
• To assess and approve/reject public testing laboratory.
• To contribute in compliance of schedule L and schedule M.
• To perform the vendor audits, if quality issue raised.
• To do audit of CTL as and when required
• To approve the purchase of chemicals and HPLC column.
• To review and approve/reject the stability data.
• To review and approval of process validation report.
• To perform the self inspection to rectify the system error, implementation in system. Review and compliance of the corrective action report of internal audit queries given to concern department for improvement.
• Investigation of market complaints with complaint sample (If provided by complainant) and control sample, in order to take corrective and preventive actions.
• Investigation, corrective action and approval or rejection of out of specification results.
• To review and approval of equipment qualification report including DQ, IQ, OQ and PQ.
• To coordinate with ARDL for technology transfer and validation activities.
• Final review, release or rejection of finished product for dispatch as per work order.
• To Inform the management of any negative trends.
• To coordinate/evaluate risk assessment with reference to laboratory product and process.
• To approve or reject starting materials, packing materials, intermediate, bulk and finished product
• To ensure that all necessary testing is carried out and associated records evaluated.
• To participate in investigation of market complaints, OOS incident, change control & deviation related to QC.
• Monitoring the plan of day-to-day work of the department.
• To review of APQR data and Continuous Process verification [CPV] reports.
• To review risk assessments of elemental impurity and nitrosamine impurity.

Job description

Role & responsibilities

To undertake overall responsibility of Quality Control Operations.

To ensure quality control lab compliance with respect to GLP/21CFR part 11/data integrity.

To verify and sign off QC reports, documents pertaining to analysis and validations.

Ensure the samples are stored according to appropriate order to obtain the required quality.

Monitoring and control of the analysis and documents.

Evaluation of analytical procedure and calibrations/qualification of instruments.

Ensure that the required initial and continuous training of quality control personnel is carried out and adopted according to need.

To Ensure the retention of analysis records and Control samples.

To Ensure the proper storage conditions for reference and working standards are maintained.

Responsible for co-ordinating regulatory inspections and ensuring laboratory compliance.

Ensure that the appropriate validations including calibration of control equipments are done as per the set frequency.

Ensure that the employees are trained based on safety and GLP principles adopted in quality control department.

Handling of analytical plans for timely release of raw materials & packing materials.

To ensure the sampling instructions, test methods and other quality control procedures are available.

Interaction and co-ordination with analytical research and development department for analytical method transfer activities.

Co-ordinate with regulatory department for registration requirements.

Review and approval of standard operating procedure and biological testing on drug product.

To handle various audits as front line auditee and compliance of the NCs raised in the audits.

To assess and approve/reject public testing laboratory.

To contribute in compliance of schedule L and schedule M.

To perform the vendor audits, if quality issue raised.

To do audit of CTL as and when required

To approve the purchase of chemicals and HPLC column.

To review and approve/reject the stability data.

To review and approval of process validation report.

To perform the self inspection to rectify the system error, implementation in system. Review and compliance of the corrective action report of internal audit queries given to concern department for improvement.

Investigation of market complaints with complaint sample (If provided by complainant) and control sample, in order to take corrective and preventive actions.

Investigation, corrective action and approval or rejection of out of specification results.

To review and approval of equipment qualification report including DQ, IQ, OQ and PQ.

To coordinate with ARDL for technology transfer and validation activities.

Final review, release or rejection of finished product for dispatch as per work order.

To Inform the management of any negative trends.

To coordinate/evaluate risk assessment with reference to laboratory product and process.

To approve or reject starting materials, packing materials, intermediate, bulk and finished product

To ensure that all necessary testing is carried out and associated records evaluated.

To participate in investigation of market complaints, OOS incident, change control & deviation related to QC.

Monitoring the plan of day-to-day work of the department.

To review of APQR data and Continuous Process verification [CPV] reports.

To review risk assessments of elemental impurity and nitrosamine impurity.