Quality & Regulatory Manager

Himachal Polyolefins Ltd1st Golden Tobacco House,S.V.Road, Vile Parle (West)Mumbai -400056Maharashtra (India)Job Title: Quality & Regulatory ManagerLocation: Kalamb Himachal PradeshDepartment: Manufacturing PlantReports To: VP Quality (Corporate office) for all Quality & Technical mattersGeneral Manager (Unit Head) for all administrative mattersContact 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 standards - Hands on experience in laboratory management, vendor management, change management & deviations - Well versed with technology transfer & validation program - Thorough 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 tools - Working knowledge on systems like LIMS, SAP, DMS applications - MS office, Google functions & tools related expertise. - Ability to liaison with regulatory authorities & manage licensing related expectations - Practical experience in delivering employee training & driving site quality training programSoft Skills:- Strategic Thinking - Planning & Prioritization - Problem Solving & Critical Thinking - Team Building & People Management - Negotiation & Conflict Resolution - Adaptability & Resilience - Strong Communication & Interpersonal Skills - Good 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 day - On-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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