​Quality & Regulatory Manager

Himachal Polyolefins Ltd1st Golden Tobacco House, S.V.Road, Vile Parle (West) Mumbai -400056Maharashtra (India) Job Title: Quality & Regulatory Manager Location: Kalamb Himachal PradeshDepartment: Manufacturing Plant Reports To: VP Quality (Corporate office) for all Quality & Technical matters General Manager (Unit Head) for all administrative matters Contact Person: Navdeep SinghEmail: gmfac@ Contact Person: Prashant KamatEmail: pkamat@About Himachal Polyolefins Ltd:Himachal Polyolefins Ltd is a leading manufacturer of different grades of Calcium Carbonate & its derivatives. We have been into the calcium carbonate business for more than 5 decades having a strong customer base in oral care (dentifrice), cosmetics, pharmaceuticals, nutraceuticals, food, plastics, paints & adhesive industries. We operate under ISO, FSSAI, WHO GMP, and various other local & international licenses, having a very strong commitment to Quality, Safety & Environmental standards. We have a state-of-the-art manufacturing plant in Kalamb Himachal Pradesh.Position Summary:We are looking for a dynamic, well versed and results-oriented site Quality & Regulator Manager to lead and manage day-to-day Quality & Regulatory related activities at our manufacturing facility located in Kalamb Himachal Pradesh (India). This role requires thorough knowledge of Quality & Regulatory function know-how pertaining to Cosmetic, Pharmaceutical & Food industry, Ability to develop & implement all the components of CGMP & Quality systems pertaining to ISO, WHO, IP/BP/USP, FASSAI standards, Competency to handle customer & regulatory audits. complaints, data integrity & documentation control protocols, licensing etc. Should have competency to train & develop plant personnel on Quality systems, SOPs, Work instructions, conduct quality review meetings, track & report quality key performance indicators & develop plans to strengthen & sustain quality excellence at the site.This position needs an individual with strong leadership & people management skills, strategic thinking and should have good command over verbal communication & writing skills in the English language. Functional skills Quality & Regulator function know-how pertaining to the Cosmetic, Pharmaceutical & Food industry.Proficiency in ISO, WHO, IP/BP/USP, FASSAI standards.Ability to develop & implement CGMP & Quality management systems pertaining to ISO, WHO, IP/BP/USP, FASSAI standardsHands on experience in laboratory management, vendor management, change management & deviationsWell versed with technology transfer & validation programThorough understating of product contamination & site micro control program Competency to handle customer & regulatory audits & complaints Hand on experience in developing SOPs, SPIs, BMR & BPRs etc. Handling Data integrity & documentation control protocols & compliances.Exposure to root cause investigation, problem solving, continuous improvement & statistical Quality toolsWorking knowledge on systems like LIMS, SAP, DMS applicationsMS office, Google functions & tools related expertise.Ability to liaison with regulatory authorities & manage licensing related expectationsPractical experience in delivering employee training & driving site quality training program Soft Skills:Strategic ThinkingPlanning & PrioritizationProblem Solving & Critical ThinkingTeam Building & People Management Negotiation & Conflict ResolutionAdaptability & ResilienceStrong Communication & Interpersonal SkillsGood command over verbal communication & writing skills in English languageQualification:  Master of Science or Doctorate in Chemistry or Microbiology.Master of Pharmacy (Quality Assurance, Regulatory Affairs, Pharmaceutics, Industrial Pharmacy)Master of technology (Chemical Engineering) Experience:  12-15 years of rich experience in Plant Quality & Regulatory affairs of a pharmaceutical,  or FMCG company of which minimum 5 years should be in a senior management position. Working hours: 6 days a week 8 hrs working per dayOn-site role requiring regular presence in the factory. Occasional extended hours or weekend work based on plant needs.Salary & Benefits  Negotiable based on Talent & Experience 

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