Job Profile : For QC Profile

Designation : QC Head

Job Description :

• To review and participate in an investigations of OOS/ OOT and incidents/Deviation to found out the root cause and ensuring the adequacy of investigation, documentation and CAPA.
• To review of electronic generated data and audit trail for various server based and stand-alone systems viz. LIMS, HPLC, GC, UV, etc. to ensure data integrity and compliances.
• To review and approval of stability sample management, Stability protocols and reports.
• To review and approval of Analytical method validation, method transfer protocols and reports.
• To review and assessment the change control, temporary change control and deviation.
• To review and approval of specification, STPs, GTPs and analytical Lab related SOPs and implement the pharmacopoeia changes.
• To prepare & review of software validation documents like URS, IRA, FS, FRA, OQ & PQ as per regulatory requirement.
• Post implementation & Periodic review of GxP system to keep the system compliant as per GAMP 5, 21 CFR part 11 requirements.
• Preparation of corporate policies, standard practices & directives as per Regulatory amendments and ensure the implementation of the same.
• Sound working knowledge in SAP QM, PM, MM module.
• Implementation & reviewing of quality systems, standards and procedure be followed as per cGMP, GDP, GLP, other regulatory guidelines.
• To monitor and validate the computer system followed by referring GAMP 5 Guideline, PIC/s 2011, 21 CFR Part 11, EU Annexure 11, Schedule M and MHRA Guideline on Data Integrity.
• To evaluate and perform gap analysis of FDA 483s, warning letters and regulatory observation.
• Involvement in the regulatory audit of the quality system and initiation as well as follow up action of corrective action if any.
• Planning and work allocation as per requirement and schedule.

Job Profile : For Production Profile

Designation : Block Head

Job Description :

• Daily and monthly Production planning, capacity planning, Inventory and shop floor control.
• Review and adjust the production schedule as per production planning.
• Make decisions about use of equipments, to organize the repair and routine maintenance of production equipment.
• Work out and implement standard operating procedures according to production operations.
• Ensure implementation and adherence to process and safety.
• Prepare and maintain production reports.
• Daily tracking of batches, yield trend & QC analysis.
• Evaluating proposed changes in product.
• Responsible for planning of the raw materials and organizing the production schedule.
• Preparation and reviewing of Master Batch records, equipment cleaning records, SOP ,process and cleaning validation qualification and all other production related documents.
• Familiar with process, equipment, manpower, co-ordinate QA, QC, Warehouse, EHS,R & D Eng.
• Department, PD LAB for better productivity and set up new products.
• Responsible for monitoring safe work environment & good housekeeping in respective area. Documents should be good and clear.
• Maintaining and updating batch production record online.
• Ensuring that all change control, CAPA, deviation, OOS, OOT are reported and evaluated and that critical deviation are investing and conducting are recorded.
• Execution & Monitoring of process validation & Cleaning Validation Batches.
• Identifying the training need for production personnel.
• Provide inputs for selection of new experiments.
• To optimize planned experimental procedures and reproduce the established ones.
• Handling of new equipments and facilities installation.
• Monitoring equipment parameters and operational norms with conformance to Standard Operating Procedures (SOP) and compliance with cGMP.
• Responsible for Handling of production documents and review.
• Trouble shooting of process/production/ product related problems. Regular investigation and analysis of such product/process related \issues and having to make necessary contributions to solve them.
• Ensured that all safety and quality measures were adhered to during production process, from beginning to end.
• Reducing cost and manpower as require.
• Planning and work allocation as per requirement and schedule.

Job Profile : For Maintenance Profile

Designation : Head/GM- Maintenance & Project

Job Description :

• Leading all Capex Projects.
• Preventive, Predictive and Breakdown Maintenance, Planning and Execution.
• Maintenance of Equipments, Root cause analysis, Energy conservation. Specific energy consumption.
• Implementing technological development to reduce maintenance cost, down time. Continual improvement projects.
• Optimum utilization of Equipments.
• Manpower planning and handling.
• All types of Piping and Structural fabrication as per (P&ID) drawings.
• Planning and execution of all project activities as per schedules.
• Erection and commissioning of process equipments and utilities.
• Stage and final inspections / running trials at supplier (FAT).
• Making bill of material, BOQ, TCS, QCS, inventory listing etc.
• Floating enquires as per requirements.
• Getting Quotations from standard manufacturers / vendors.
• Technical and commercial comparison.
• Commercial negotiation, Preparation MIS.
• Follow up for materials, inspection etc.
• Any other work allotted by Management.

Job Profile : For QC Profile

Designation : ADL-QC

Job Description :

• Handle all the Literature Search and method development of Analytical procedures (HPLC, GC, Chiral HPLC, IR, WET analysis).
• Troubleshooting of Analytical methods during development.
• Troubleshooting of Instruments.
• Validation of analytical procedures.
• Technology transfer of Analytical procedures.
• Implementing innovative methods to reduce the time of analysis.
• Setting of specifications for Analytical Data Review.
• Interpretation of Analytical Data.
• Resource Planning & Technical Documents preparation and review.
• To write, maintain & review analytical operational and calibration SOPs.

Job Profile : DGFT Profile

Designation : DGFT

Job Description :

The candidate should carry out all these functions independently and without the help of consultant

• To apply Advance License application.
• To apply for redemption of license and ensure redemption.
• Attending DGFT Office for various DL Explanations/ Advance license applications/ Redemptions/ any other queries of DGFT.
• Applications for MEIS & ROTAC.
• Handling IGST refund.
• Keeping track of Advance License Utilization.
• Keeping track and collection of all documents necessary for redemption of advance license.

Job Profile : Manager

Designation : Sr. Manager- QA

Job Description :

1. Approval of Quality documents such as SOP/QAP/MVP/BMRs/MFCs/Dept. manuals & all types of validation protocols/ AWRs, Reports, equipment qualification (DQ/IQ/OQ/PQ) etc.
2. Approving, change control, deviations, APQR, Product recall out of specifications results of RM/PM & Finished product & Out of Trend & investigation.
3. Approval of Approved vendor list of Raw Material/ Packing Material.
4. Approval of certificate of analysis of finish product. Manufacture at Vital Healthcare Pvt. Ltd.
5. Handling of Internal audits & vendor audit, Market complaint, return Goods, Change Control system, Deviation system, Out of specification, Corrective & Preventive action (CAPA), Incident reporting & investigation, deficiency of compliance of vendor audit & internal audit.
6. Preparation of audit compliance report, Approval of self-audit schedule & training schedule.
7. Approving all procedures and changes affecting the quality of intermediates or APIs.
8. Approving all specifications and master production instructions.
9. Work distribution in QA dept. & Assign job responsibility QA employee.

10. Approval of Validation process, cleaning validation, analytical methods, equipment qualification & computer system.

11. To coordinate validations & ensure operation in plant with validation compliance.

12. Preparion of EDQM, USFDA, WHO, GMP & audit CAPA.
13. Training to all employees of 21CFR Part 11, ICH Q7 GMP & WHO TRS.
14. You are responsible of both unit for all QA activities.