Job Description
Quality Control analysis :
- To plan and provide the analysis support as per approved specification & test procedure and standard operating procedures.
- To maintain and manage the quality control departmental activity of all the section i.e. Chemical analysis, HPLC / GC / RM/ stability/ and microbial analysis as an overall QC-In charge/HOD.
- Ensure that, all the analysis as per customer specification is done (for dispatch) as per the planning (planning to be taken as per delivery instruction). To review and monitor daily activity of dispatches and report to Quality Control Head.
- To approve/reject raw material/packing material based on the analysis data.
- To approve / reject the intermediate and finished product based on the analysis data.
- Review and approval of certificate of analysis for raw material, packing materials, intermediates and APIs.
- To plan for Joint analysis with R& D personnel during analytical method transfer on HPLC/GC.
- Coordinate with Purchase, warehouse, engineering, QA and Production departments to ensure smooth functioning of department and analysis support.
- Planning of analysis as per laid down specifications and cross review & approval of analysis data of scale up and Validation batches, commercial batches for Raw materials/ packing materials / in process/ Intermediate / microbial analysis/ and API analysis data whenever required.
- To plan and approval of qualification and maintenance of working standard / in-house reference standards for Raw materials/ Intermediates/APIs.
- To achieve production target for dispatches without any delay for finished product.
- To coordinate with marketing, QA and production for prompt analytical support to dispatch the material as per customers requirement.
- To ensure timely analysis of stability samples as per stability schedule and timely update to regulatory department.
- To ensure LIMS Operations.
cGMP:
- To maintain the GLP and GMP practices & ensure all standards procedures in Quality Control laboratory followed effectively.
- To review the Standard Operating procedures, work sheets/ stability protocols / validation / qualification and other relevant documents of Quality control department.
- To review the supplement specification as per customer requirement.
- To plan for analyst qualification activities and impart on job training to all subordinates.
- To ensure the qualification/preventive maintenance and calibration has been followed as per approved scheduled and records maintained.
- Ensure CFR-21 –Part 11 practices are followed effectively with online documentation and periodic review of audit trials for the computerized system / instruments.
- Ensure timely completion of NQI/QI/OOS/OOTs, deviation, customer / market complaint investigation and change control
- To ensure the finished product material is analyzed as per customer requirement.
- To ensure the quality record as per cGLP/ISO system.
Safety :
- To ensure awareness to MSDS.
- To educate /Train supervisor/ workmen in handling of material to prevent accident.
- To ensure the use of safety equipment while handling of material.
- To ensure the storage of retain samples at proper place with segregation to prevent contamination, cross contamination and accidents.
Wastage avoidance /reduction :
- To ensure no spillage of material while sampling and during analysis.
- To ensure no misuses / wastage of reagents & solvents & packing material.
- To plan the HPLC analysis on campaign basis to minimize the use of costly solvent when extra requirement of customer.
Training :
- To impart training as per cGMP, GLP, ISO system, Instrumental and technical training to all the concern staff.
Inter departmental co-ordination :
- To coordinate with production department for daily analysis of finished product In-process and Intermediate samples to avoid the delay for the same.
- To coordinate with QA department for cGLP/good documentation practice.
- To coordinate with marketing department for dispatch of finished product.
LIMS :
- Authorized person for Change control, CAPA, Deviation, OOS and OOT in LIMS.