The incumbent is responsible for planning, allocation of work and checking of all analytical data generated during the analysis of Raw Materials, intermediate product, finished product, Stability, Post Importation Testing (PIT) and special request (non-routine) samples in accordance with procedure.
Key Accountabilities
- People Management
- Encourage the teamwork spirit and motivate the team.
- Communicates effectively with staff, departments & external clients to ensure timeous resolution of queries.
- Manage the talent and delegate effectively
- Manage diversity
To plan and schedule the workload of the instrument laboratory and Ensures that the QC laboratory maintains GMP Compliance, safety standards and good housekeeping.To ensure thatRawMaterials and special request (non-routine)are sampled and tested according to prescribed monographs and meet specification prior to use
- Manage QC resources Review of work output report and analyst performance
- Monitoring routine sampling and analysis of samples.
- To ensure the compliance to all the procedures and policies
- Allocation/Monitoring resources for an effective testing/Release of Raw Materials/Finished products.
- Review and Check the logbooks/Preparation of laboratory solution.
- Review and approval of analytical reports of chemical testing for batch release.
- Monitoring maintenance of received samples at the required storage condition.
- Preparation/Review of specifications or monographs.
- Review of trend reports for APQR
- Release and reject material on Syspro.
- Issuance of TDS. Handover of sample, ADS/TDS along with other supporting documents and correct specification to the analyst for analysis.
- Preparation of certificate of analysis for post importation products and providing certificates to customer. (When required)
- Manage the laboratory maintenance, validation & calibration programme
- Manage the team timekeeping, leaves and assist with disciplinary procedures, recruitment and retention of staff.
- Adherence to laboratory best practices to ensure testing is conducted effectively
- Upkeep of Laboratory working area i.e. good housekeeping.
- Maintain the high standard of safety in the QC laboratory.
- To ensure adequate identification and segregation of test samples to avoid mix up and cross contamination.
- To ensure destruction of expired samples and tested and released samples
Ensure SOP training and analyst qualification is conducted to improve efficiency testing time.
Responsible for providing technical support and analytical training to Quality Control personnel.
Oversee first line trouble shooting on QC laboratory processes (equipment, materials) and delegate corrective actions to QC personnel.
Ensures development of improved analytical methods to the latest monographs
QC Systems
- Conduct the out-of-specification, analytical incidents and out-of-trend investigations
- To ensure compliance of equipment, SOPs, internal/external findings and investigate non-conformances
- Ensure that major deficiencies, errors, deviation from SOPs, compliance with QC programs and GMP are in line with appropriate measures.
- Ongoing development, evaluation & implementation of quality control testing programmes in conjunction with Regulatory, QA, production and Customers
- Ensure that the sample to be tested at approved contract laboratory should be sent on time wherever applicable and follow up for the same should be taken
- To ensure compliance of equipment, SOPs, internal/external findings and investigate non-conformances
Educational qualifications:
National Diploma/ BTech in Analytical Chemistry / Biotechnology and or B.SC. Applied Science
Relevant Experience
5 years in a pharmaceutical QC laboratory
