Quality & Regulatory Manager
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Job Description
Job Title: Quality & Regulatory Manager
Location: Kala Amb - Sirmaur, Himachal Pradesh
Department: Manufacturing Plant
Experience: 12–15 Years
Salary: 18–24 LPA
Reporting To
- VP Quality (Corporate Office) – For all Quality & Technical matters
- General Manager (Unit Head) – For all administrative matters
About Himachal Polyolefins Ltd.
Himachal Polyolefins Ltd. is a leading manufacturer of different grades of Calcium Carbonate & its derivatives. We have been in the calcium carbonate business for more than five decades, serving a strong customer base across the oral care (dentifrice), cosmetics, pharmaceuticals, nutraceuticals, food, plastics, paints, and adhesive industries.
We operate under ISO, FSSAI, WHO GMP, and various other local & international certifications, with a strong commitment to Quality, Safety & Environmental standards. Our state-of-the-art manufacturing plant is located in Kala Amb, Himachal Pradesh.
Position Summary
We are looking for a dynamic, well-versed, and results-oriented Site Quality & Regulatory Manager to lead and manage day-to-day Quality & Regulatory activities at our manufacturing facility in Kala Amb, Himachal Pradesh.
This role requires thorough knowledge of Quality & Regulatory functions related to the Cosmetic, Pharmaceutical & Food industries, along with the ability to develop and implement CGMP & Quality Management Systems in compliance with ISO, WHO, IP/BP/USP, and FSSAI standards. The candidate should also be competent in handling customer and regulatory audits, complaints, data integrity, documentation control protocols, licensing, and related compliance requirements.
The incumbent should be capable of training and developing plant personnel on Quality Systems, SOPs, and Work Instructions, conducting quality review meetings, tracking and reporting Quality KPIs, and implementing initiatives to strengthen and sustain quality excellence across the site.
This position requires strong leadership and people management skills, strategic thinking, and excellent verbal and written communication skills in English.
Functional Skills
- Quality & Regulatory function expertise in the Cosmetic, Pharmaceutical & Food industries.
- Proficiency in ISO, WHO, IP/BP/USP, and FSSAI standards.
- Ability to develop and implement CGMP & Quality Management Systems.
- Hands-on experience in laboratory management, vendor management, change management, and deviation handling.
- Well-versed in technology transfer and validation programs.
- Strong understanding of product contamination control and site microbiological control programs.
- Competency in handling customer and regulatory audits and complaints.
- Hands-on experience in developing SOPs, SPIs, BMRs, and BPRs, along with managing data integrity and documentation control protocols.
- Exposure to root cause analysis, problem-solving, continuous improvement, and statistical quality tools.
- Working knowledge of LIMS, SAP, and DMS applications.
- Proficiency in MS Office and Google Workspace tools.
- Ability to liaise with regulatory authorities and manage licensing requirements.
- Practical experience in delivering employee training and driving site quality training programs.
Soft Skills
- Strategic Thinking
- Planning & Prioritization
- Problem Solving & Critical Thinking
- Team Building & People Management
- Negotiation & Conflict Resolution
- Adaptability & Resilience
- Strong Communication & Interpersonal Skills
- Excellent verbal and written communication skills in English.
Qualifications
- Master of Science or Doctorate in Chemistry or Microbiology.
- Master of Pharmacy (Quality Assurance, Regulatory Affairs, Pharmaceutics, or Industrial Pharmacy).
- Master of Technology (Chemical Engineering).
Experience
- 12–15 years of experience in Plant Quality & Regulatory Affairs within the Pharmaceutical or FMCG industry, including a minimum of 5 years in a senior management role.
Working Hours
- 6 days a week, 8 hours per day.
- On-site role requiring regular presence at the manufacturing facility. Occasional extended hours or weekend work may be required based on plant requirements.
Salary & Benefits
- Negotiable based on talent and experience.
Designation
Quality & Regulatory Manager
Key Skills
Industry
MANUFACTURING
Functional Area
Manufacturing
Employment Type
Full Time
Education
Graduation/Diploma
Job Type
Work From Office
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