Job Description

GMP GDP EXCiPACT EFFCI ISO 15378 and ISO 22716 Auditor for
Knowledge Business:  REPORTING LINE
• Head Technical

LOCATION
• Mumbai
PRIMARY RESPONSIBILITES
• Execute the audits, Prepare documentation and Sales support
• Nos. of audit man-days employed in audits and trainings
• Turn around time of sending audit packs to certifying office post audits
• Technical accuracy as per guidelines of audits packs
• Sociable with good market recognition and understanding
• Presentable with the right mix of authority and convincing capability
• Analytical capability and prompt decision making capability

SPECIFIC RESPONSIBILITES
In case of GMP
• At least 3 years of relevant work experience (related to GMP in cosmetic and/or pharmaceutical
manufacturing environment, chemistry, food, microbiology.
In case of EXCiPACT
• 5 years experience as A technical, managerial or professional role within an excipient or API supplier or
a pharmaceutical/cosmetic company
• A role with responsibilities that include conformance to GMP requirements
• Performing QMS or GMP audits of chemical operations to a recognized standard, e.g. ISO9001,
ISO22716, ICHQ7, ...
In case of EFfCI
• Minimum of 2 years work experience in the quality unit at pharmaceutical/cosmetic/chemical/food
manufacturing company with responsibilities that include conformance to GMP in a quality assurance
position, or
• At least 5 years audit experience in numerous pharmaceutical / cosmetic / chemical / food
manufacturing operations to a recognized GMP standard (i.e. ISO/FSSC22000, ISO22716, ICHQ7,
…).
In case of GDP
• At least 5 years of relevant work experience (related to Good Distribution Practice and/or Quality and/or
Food Safety Management Systems),
• With at least 2 years in a quality assurance, food and/or health safety related position, reviewed and
verified.
In case of ISO 15378
• Over 3 years of technical working experience in Pharmaceutical, Chemical, Medical Device, Cosmetics
or food, packaging material related industry
PROFILE
Qualifications:
• Education : The candidate shall have a tertiary education in a scientific discipline (chemistry, biology,
microbiology, pharmaceutical, food technology or cosmetic science).
Experience:
• Minimum Years : 3-5 Yrs. And mention the detailed work experience in the above point.
• Be trained against ISO9001;
• Meet the requirements for Lead Auditor qualification for ISO9001 or other quality related management
systems based on the standard ISO high level hierarchy, or be an EXCiPACT registered auditor;
• Demonstrate the execution of at least 5 audits prior two years against ISO9001 requirements or
equivalent that includes conformity to GMP (i.e. ISO/FSSC22000, ISO22716, ICHQ7, EXCiPACT…).
  Scope of job /Activities handled: Execute audit, Plan sales meeting with client and support sales where required

REQUIRED SKILLS
• Ability to lead and motivate the audit team
• Manage team performance
• Plan, organize and implement the audit plan
• Coach team members on the auditing activities
• Interact with all levels of management, consultants and clients
• Excellent interpersonal and communication skills
• Strong organizational skills and flexibility

Required Knowledge, Skills, and Abilities

• interpersonal
• communication
• team management
• iso

Education + Experience

• Qualification: Degree