Himachal Polyolefins Ltd 1st Golden Tobacco House, S.V.Road, Vile Parle (West) Mumbai - Maharashtra (India) Job Title: Quality & Regulatory Manager Location: Kalamb Himachal Pradesh Department: Manufacturing Plant Reports To: VP Quality (Corporate office) for all Quality & Technical matters General Manager (Unit Head) for all administrative matters Contact Person: Navdeep Singh Email: Contact Person: Prashant Kamat Email: 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 program Soft 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 language Qualification: 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
Job Title
Quality & Regulatory Manager