Qa/qc Executive

Job Title Quality Check QC and Quality Ana QA Location AMHEDABAD Job Type Full-time Job Location Pirana Ahmedabad Joining Immediate Salary 20 to 25 K p m Qualificaiton B Sc M Sc B Pharm M Pharm Job Overview We are seeking a detail-oriented and proactive Quality Check QC and Quality Assurance QA Specialist to join our team This role is responsible for ensuring the highest standards of quality in our products and services overseeing the quality control processes and implementing assurance protocols to meet industry standards and company requirements Key Responsibilities QC 1 Responsibilities of Quality Control Laboratory including Instrumental Lab Chemical Lab 2 To ensure the compliance of current Good Laboratory Practices and Standard Operating Procedures in the Q C Laboratory 3 To prepare the working standards as per the guidelines and pharmacopoeias 4 Review of QC documents test protocols and analytical reports 5 To carry out the sampling and testing of raw material and packing material according to approved procedure 6 Responsibilities for testing and approval or rejection of packaging materials after discussion with QC Head 7 To recommend the release of Raw Material and Packing Material in standard format 8 To intimate the Officer Stores and QC Head for the failure of any packing material however if the QC Head is absent then intimate the status of the same to G M Technical Director 9 To record all the data related to the testing on line on day-to-day basis and ensuring the traceability of it 10 To ensure the status tag on the released material and transfer of such material in the released area 11 To review and updating of all SOPs as per requirements of GLP on regular basis 12 To participate in execution of all validation program like process validation cleaning validation analytical method validation etc 13 To check the cleaning records of laboratory 14 To make documentation of all analysis including raw data checking of all data and proper storage of data 15 To charge the product for stability and analysis of all stability samples and compilation of stability data 16 To provide response to queries received from regulatory marketing departments 17 To maintain the calibration record and annual maintenance contract records of all the instruments in QC Laboratory 18 To ensure the timely review and updating of all standard test procedures and specifications of raw materials and packaging materials on regular basis to meet regulatory requirements 19 To ensure the standardization of volumetric solution preparation of reagents as per schedule and verification of its documentation 20 To develop the new analytical method and Standard Testing Procedures STPs for in-house or pharmacopoeia methods and prepare the method validation report 21 To maintain the record of retain sample by means of their inventory their periodic check and their disposal 22 To train and develop all QC staff on GLP advanced analytical techniques and their evaluation on periodical basis 23 To evaluate the requirements of HPLC GC columns reference standards chemicals reagents etc and raise PR for procurement of the same 24 In absence of QC Head take care of the day to day activities of QC department including approval of documents and release of material 25 If you take leave your work responsibility handover to other QC Executive Officer Authority 1 To carry out all the necessary test and recording their result thereof for all the material 2 To check the stores and ensure the implementation of GMP norms in the stores 3 Not to allow any material inside the plant if material is not from the approved vendor or if it is not as per the specified standards 6 1 Over all responsibility of Quality Assurance Department 6 2 Vendors approval for RM PM 6 3 Periodical Quality Audit 6 4 Activities related to Drug Control Authorities 6 5 Evaluation of Product Complaints Product Recall 6 6 Validation and Qualification 6 7 GMP Training to Staff 6 8 GMP Implementation in the factory 6 9 Co-ordination with various departments to implement cGMP in Plant 6 10 Market Authorization of Products 6 11 Release of batches for Sale 6 12 Evaluation of change control and Deviation in system and process 6 13 Assure the operation as per Quality Policy 6 14 Execution and review of QMS in plant 6 15 Other jobs assigned by seniors as and when required EXPERINCES Minimum 2 year Salary range 20 to 25 k