Cargill Pharma
& Nutrition Manager – Quality Master's degree in a Pharmacy(M. Pharm)
Job Purpose
and Impact
The FSQR
Manager will be a subject matter expert with high skill level in Formulations
for sterile injectable manufacturing operations with functional expertise in
Quality Assurance department along with regulatory compliance
(USFDA/EDQM/MHRA/TGA, WHO & Schedule-M).
Responsibilities
include developing, implementing and maintaining cGMP at multiple Third party
manufacturers of Veterinary Drugs, Nutritional products, processes and programs
built to assure regulatory compliance.
Risk
Assessment, Data Integrity and regulatory compliance of Third party operations
This position
performs work under limited supervision as an independent contributor while
working with cross functional teams to support business needs.
Key
Accountabilities
You will
conduct sample analysis from various sources including but not limited to COA,
Product packing records etc., to regularly release the batches to market.
Provide insights and information on Drug formulations, process flow,
equipment/instruments used in sterile / non-sterile formulations (injectables,
tablets/bolus, internal / external powders, nutritional liquids/powders)-both
API and formulations and figures out whether current processes can be optimized
to increase compliance efficiency.
You will
manage third-party manufacturers with respect to complete Quality Assurance
activities and collaborate with team both internal and external to interpret
data and analyse test results.
You will
Collect, analyze, and documents test data to make sure products meet customer
requirements, quality standards, and expectations.
You will work
with cross function teams to improve an effective food safety, quality and
regulatory culture. Establish, communicate and improve Bench marking of Third
party manufacturers using various criteria.
You will be
responsible to conduct scheduled/un-scheduled Third party audits/ visits/
reviews to understand regulatory compliance/ Data integrity issues. Provide
Audit report and conduct regular follow-up to ensure compliance of action plan
within the target timeline.
You will
Handle Quality management processes including changes to process, artworks,
deviations, Out of specifications.
You will
Release/reject/hold of material in ERP system.
You will be
responsible and accountable for Not of standard Quality (NSQ) notice, market
complaints
You will be
responsible to ensure the complaints are investigated using latest tools to
arrive at Root-cause, implement corrective actions and mitigate/eliminate
through risk assessment.
30-40% time
required to travel
Other duties
as assigned"
Qualifications
Minimum
Qualifications
• Master's
degree in a Pharmacy(M. Pharm)with minimum 4-5 years of work experience in
carrying out sterile injectable manufacturing and 2-3 years in Quality
Assurance department in reputed company
• This
position may require travel related to audits/ new facility review/
investigation review up to 30%
• This
position require proficiency in communication, multi language (Hindi, English)
skills and also in preparation of presentations, Microsoft word, excel and graphical
representation of data.
Preferred
Qualifications
• Experience
of 4-5 years in Sterile injectable manufacturing and 2-3 years in Quality
Assurance department in Human / Veterinary Formulations
• Excellent
Written and verbal communication skills
• Hands-on
Technical knowledge in Sterile and Non-sterile manufacturing facility operations
and Quality Assurance
Prior
Beneficial Experiences
Experience of
6-8 years working as a Quality Assurance Manager for Third party operations in
a reputed Pharmaceutical company is preferred.
How you will
be successful in this role
You will be
successful in this role by establishing robust Quality Assurance practices
related to compliance at Third party operations to achieve zero recall/ Quality
issues.
Skills and
experiences you may gain in this role
• Strong
written and verbal communication skills • Basic business acumen and the ability
to partner and communicate effectively with business counterparts
• Thorough
working knowledge of Pharmaceutical industry practices and standards
• Strong
knowledge in ICH, WHO guidelines and Schedule-M rules
Proven ability to
deliver processes effectively to optimize Third party manufacturers to ensure
regulatory compliance at any given point of time"
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