Planning & control:
Ensure completion of analysis within time limit and as per regulatory guidelines & in house SOPs.
Properly schedule the analysis & ensure accuracy & precision should be maintained by chemists while testing.
Set priorities for department staff & inline the activities as per the need of the organization.
Implement SOP to bring process efficiency & to save analysis time
Maintain c-GMP, EU-GMP, WHO & ISO standards for incoming materials, ensuring stringent adherence to quality standards.
Participate in OOS investigation.
Approve and reject the raw material, finish product & intermediate product and packaging material.
Approve all the standard test procedures and specifications related to quality control.
GAP Analysis: Periodically perform a process audit to identify the gap between set standards & actual working. Prepare report of this analysis & ensure the gap to be filled within a stipulated time period.
Identify the quality needs in relation to overall strategic plans.
Avoid any kind of deviation in the SOP & adhere to the quality policy of company.
Analysis & Calibration:
Ensure accurate & timely analysis of solid oral formulation, raw material, packing material, finished product & inprocess product.
Monitor proper allocation of samples to chemist.
Track the average analysis time of samples & set standards in order to keep in control the total time required for analysis.
Ensure that all instruments are calibrated periodically & review documents of calibration
Ensure proper maintenance of & updation of records of analysis as per drug rules.
Ensure proper qualification & calibration of the new & existing instruments/equipments in QC dept.
Working Standards, Reference standard & control samples management:
Ensure proper preparation & maintenance of working standards & reference standards.
Ensure proper monitoring & observation of control samples periodically and to report to the in-charge.
SOP preparation & compliance:
Ensure preparation of SOP relating to quality control as per current guidelines & its 100% compliances.
Perform critical analysis of existing SOP & suggest changes (if any) required in present system.
Review raw material and finished product planning as per production schedule.
Review the RM/PM/FG report.
Review of Raw material, finished product & stability samples.
Review of technical documents received from Validation cell in QC
Responsible for review of all quality related documents such as SOP, specification, method of analysis.
Responsible for maintaining all QC documentation records to comply the regulatory requirements.
Identify at least two cost reduction technique to control the total cost of analysis without any production delay
Periodically educate the chemist on ways & means of cost effective analysis.
Ensure proper utilization of chemicals, glassware, machineries & all other facilities of QC department.
Safety & Hygiene:
Ensure a safe work environment for all chemists in QC and ensure that they are working as per safety guidelines of the company.
Ensure good work condition is maintained in QC to all chemist should follow all GMP norms related to personnel hygiene, while working.
Set goals for next 2 years for QC team, goals should be specific, measurable, realistic and time bound. It should also include benchmark and target date of completion.
Prepare Action plan for the development of subordinates, management for non-performers and top performers of the department.
Participate in recruitment & selection of staff for QC & all other technical persons in the company.
Participate in performance reviews of technical staff.
Provide timely inputs for identifying training needs of QC staff.
Other important work:
Participate in successfully completing Internal Audits & implementation of corrective & preventive action plan.
Give suggestion in vendor selection.
Check and analyse daily reports of chemist/subordinates.
Ensure the monthly report of department should be submitted before 7th of every month to General Manager QA. Content of Monthly report:-
Total no. of analysis planned & done in a month
OOS investigation (if any) carried out & its results.
Occupancy data of machine & chemist
Chemical consumption data(comparative analysis with last month)
Breakage of glassware(if any & comparative analysis with last month)
Trainings given to chemist in the month.
Deviations done (if any) along with cause & justification.
Corrective & preventive action plan for development of department.
Coordination with: Interdepartmental coordination for ensuring smooth functioning of the department on following points:
Quality related issues, deviations (if any) & to solve all routine problems related with department VP Quality
Product priority & planning VP Production
Problems related with Sampling of RM Warehouse Incharge
Development of department (excluding routine issues) MCM
Strong in people management.
Should have exposure of domestic & regulatory solid oral formulation manufacturing companies.
Should have minimum 5 years of exposure at managerial capacity.
Average stability in last companies should be not less than 4 years.
Preference to candidate from Vidharbha Maharashtra or strong reason for relocation.
Experience 15+ Years (at least 5 year at managerial level)
Qualification B. Pharm./M. Pharm./ M. Sc. With any additional Quality related qualification.
Age Range Around 35Years.
Team Handling Yes (Around 90 member team).
Candidate Should be from "PHARMA COMPANY"
Between 15 -20 yrs. (minimum 5+ yrs. at managerial capacity)
Should have entire exposure in oral solid dosage (e.g. Tablet, Capsule, pallets etc.)
Should have exposure of regulatory audits (e.g. EUGMP, USFDA, MHRA etc.)
Should have exposure of entire QC function (e.g. RM, IP, FG, PM, Stability, Validation, & Micro)
Should have exposure of large team handling (e.g. Asst. Manager, Team Leader, Executive, Officer, & Chemist)