| Recruiter Type: | Company |
| Company Name: | VIDIT HEALTHCARE |
| Address: | KISHANPURA NEAR MANKIND UNIT-1 PAONTA SAHIB DISTT. SIRMOUR H.P. 173025 |
| Contact Person: | MR. SURESH SONI |
| Email Address: | ss@vidithealthcare.com |
| Required in: | Formulation |
| Job Department(s): | Quality Control, Quality Assurance |
| Job Title: | QC MANAGER AND QA HEAD |
| Qualification: | M.Sc, M.pharma, B.pharma |
| Job Details: | Candidate shall be able to Manage and maintain an effective Quality Assurance program for the plant in alignment with WHO-cGMP Procedures and capable of achieving certifications. • He shall be primarily responsible to prepare the documents for WHO-cGMP certification till the audit, compliance and achieve the Certificate • The candidate ,Should understand the complete knowledge and soul of Quality Assurance, TQM, and QMS. • Should be able to create, and execute all process documents, quality documents, SOP's, through knowledge of Validation of all types is must either its Product validate or Process validation or Cleaning validation or any other related validation. • No, Copy paste of documents shall be there understanding the logic of documents is must. • Shlould be able to handle, queries and Audits, related to WHO-cGMP procedures. • Through knowledge of minimum documentation requirements as per WHO-cGMP regulatory level should be implemented and executed. • Should be able to build a team and work in Team Culture, Handle the matters and Product Recalls with deep Investigative nature. • The candidate shall have strong logical reasoning, humble, smart, prompt and pro-active. • Should be able to directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible. • Review operating procedures to ensure compliance with all related procedures, instructions and the Quality Manual. • Conduct plant Quality Management Review meetings of the plant quality system • Establish and monitor plant Quality Metrics used to evaluate the effectiveness of the Quality System • Manage Quality Staff at site to assure knowledge and execution of site Quality System • Assure proper use of change management associated with validated processes • Assure execution of internal audit program • Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification and customer requirements Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness |
| Regulatory Exposure: | Required |
| Audit Experience: | WHO, PICS |
| Experience: | MORE THAN 12 YEARS |
| Vacancies: | 1,1 |
| Additional Details: | To plan analytical method validation and verification. • Handling of software (LIMS, DMS, QAMS, SAP). • To prepare and review analytical method verification and validation protocols/reports for the regulatory market. • To prepare and review of installation qualification, operational qualification, and performance qualification documents of new instruments set up in the laboratory. • To prepare and review all the standard operating procedures, standard testing procedures, specifications, general testing procedures, protocols for testing of raw materials, and finished and stability studies of the quality control department. • Coordinate AMC and PM of instruments. • To review all QMS documents. • To investigate laboratory incidents, deviations, of specifications results related to in-process, semi-finished, finished products, raw material, and stability product testing. • To plan and perform process validations, and cleaning validations of routine products. • Monitoring of operation and calibration of quality control instruments. • To conduct the audits of contract testing laboratories and prepare the technical agreements after the compliance report. WE ARE LOOKING FOR A QUALITY CONTROL MANAGER (FEMALE PREFERRED) WITH MIN. 10 YRS OF EXP. AT OUR FORMULATION PLANT AT DEHRADUN |
Job Posted on Jan 25, 2023
