REGULATORY AFFAIRS AND COMPLIANCE OFFICER
REGULATORY AFFAIRS AND COMPLIANCE OFFICER
JOB DESCRIPTION
DUTIES & RESPONSIBILITIES:
1. Responsible with the preparation of regulatory documentation including regulatory submissions, drafting Product information, Consumer Information, literature searches to support submissions, finished product analysis, changes in manufacturing, pack sizes, packaging changes and other regulatory activities.
2. Maintains database with information on registration status of product portfolio.
3. Ensures that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local regulatory requirements, commitments and agreements.
4. Undertaking and supervising regulatory inspections
5. Coordinating with local regulatory authorities.
6. Coordinating with clients’ Regulatory Officer.
7. Negotiating with regulatory authorities for marketing authorization.
8. Lead and set direction for the sites’ internal and external quality program.
9. Conducts internal audit and provide assistance for 3rd party audits.
10. Monitors CAPA Plan compliance of each department for GMP deviations and findings during internal and regulatory audits.
11. Ensures training has been provided to QA before undertaking specific duties and that all training is recorded in training records
12. Investigation, resolution and management of customer complaints
13. Oversees document control and ensures that QMS and HAS documents are updated, protected and retained.
14. Oversees plant trial, microbiological and stability testing performed by Quality Analyst.
15. Perform other related tasks assigned by immediate supervisor / management.
JOB QUALIFICATION
JOB SPECIFICATION:
- 5-8 years of experience in Food / Fast Moving Consumer Goods (FMCG) / Medical Device / Pharmaceutical manufacturing or equivalent (relevant to the specialist area of expertise)
- College Degree, Science (Biological / Physical / Pharmaceutical / Healthcare)/ Food Technology / Engineering / Manufacturing / higher (Master's / PhD)
- PRC license is an advantage.
- Knowledgeable in Microsoft Office Suite (Excel, PowerPoint, Word). Excellent organizational, analytical, and problem-solving skills. Strong functional understanding of local and international regulatory programs.
OTHER JOB REQUIREMENTS
WORK LOCATION
Las PiñasCOMPANY PREVIEW
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Telephone No.
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Company Size
COMPANY OVERVIEW
Integrated Manufacturing Services Providers, Inc. is a company that evolved from humble beginnings in 1998. It started its operation as a toll manufacturing service provider for a Multi-National Company who is market leader in the powdered juice segment. It is in serving this company that IMSPI learned the values of quality and adhering to the correct process and protocols. Gaining the trust and confidence of its sole client, the Company was also given the opportunity to produce its leading baking powder and 3-in-1 coffee mix.
As the company progressed, the need for a systematic and organized approach in producing the products has become more necessary hence Quality Systems were implemented throughout the manufacturing operations.
In 2006, the Company lost its sole client due to the increasing prices of sugar in the local market. The client switched all its manufacturing operations for the powdered beverages to its manufacturing facility in Thailand. Rising from this adversity, IMSPI and its people believed that if a door closes a window of opportunity opens. The Company decided to venture into producing its own products but quickly realized that it was not yet prepared to compete head on in the mainstream market. The strategy was to introduce its capabilities in producing quality powdered beverages thus giving birth to the Hot Bevs vending business.
However, producing the requirements of the vending business cannot sustain the current operation. The problem of utilizing its huge facility is still glaring hence the Company decided to open its doors to new clients who are searching for a reliable service provider who can offer multiple solutions to their unique powder food mixes and beverage manufacturing requirements.
The Company prides itself to be accredited by FDA as cGMP, Islamic Da'Wah Council of the Philippines as HALAL and adheres to HACCP Food Safety standards. To date, IMSPI has strengthened its Research and Development Group to create more innovative products it can produce and offer its client. It has also evolved into a full service food and beverage manufacturing facility that is capable of being a total solutions provider who can collaborate with business partners to introduce First-To-Market products and concepts in the industry.
WHY JOIN US?
VISION
We are a manufacturing service provider in the food and beverage industry who will be known for its strong product innovation abilities and strict adherence to product quality standards and good manufacturing practice.
MISSION
Pursue excellence in everything we do thereby keeping our customers continuously satisfied.
Introduce products that would complement our existing capabilities and offer new market opportunities to our customers.
Ensure adherence to our quality management system as a means of assuring that products conform to specified quality requirements, food safety and regulatory requirements.
Promote a sustainable operation that would eventually allow for a corporate social responsibility campaign