​Quality & Regulatory Manager

Himachal Polyolefins Ltd

1st Golden Tobacco House,

S.V.Road, Vile Parle (West)

Mumbai -400056

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:gmfac@himpol.com

Contact Person: Prashant Kamat

Email: pkamat@himpol.com

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.

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.

• 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

• 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