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ABOUT US

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) Technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.

PQM+ & COVID-19

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, and dietary supplements manufactured, distributed, and consumed worldwide. In Pakistan, Promoting the Quality of Medicines Plus (PQM+) Program, is a Cooperative Agreement between the United States Agency for International Development (USAID) and USP. This cooperative relationship supports Drug Regulatory Authority of Pakistan (DRAP) for regulatory reforms, quality assurance systems and strengthening the quality control laboratories in Pakistan. Moreover, PQM+ also provides technical capacity building in close coordination with DRAP and provincial health authorities.

ACTIVITY OBJECTIVE:

PQM+ team intends to provide support to PPE manufacturers to obtain CE-Marks to ensure conformity with health, safety, and environmental protection standards for their products. This European certification also ensures good quality PPE manufacturing by the manufacturers. This technical assistance will help to improve PPE manufacturers’ level of awareness on international standards & CE Certifications. For the said activity, PQM+ requires to hire a third-party consultant/firm to support PPE manufacturers in the CE certification process.

  1. To conduct gap assessment of PPE manufacturers for achievement of CE-Mark.
  2. In close collaboration with the management team, lead the follow-up of needed corrective and preventive actions following audits, along with application of root cause analysis principle and process.
  3. To take active role in developing Quality Manual, policies, procedures/SOPs, and operation guidelines with reference to CE Mark certification or any other applicable standards.
  4. To conduct required training for the staff.
  5. To assist PPE manufacturers in preparation and submission of application for CE Mark Certification.
  6. To support PPE manufacturer to address the gaps for CE-Certification.
  7. To support PPE manufacturers to obtain CE Mark for one product.

MANDATORY DELIVERABLES:

  • Gap Assessment Report of selected PPE manufacturers.
  • Follow-up reports on progress including CAPA updates.
  • SOPs/documents developed or reviewed for CE Certification.
  • Product CE Mark Application submissions by selected PPE manufacturers.
  • CE-Mark certification for one product for each of the selected PPE manufacturers.

MINIMUM REQUIREMENTS 

  1. At least 05 Years’ experience in relevant field.
  2. Hands-on experience and work, with an understanding of Product CE Mark.
  3. Demonstrated ability in developing policies, regulations, and guidelines related to Product CE Mark Requirements

PERIOD OF PERFORMANCE 

The scope of the work defined herein should be implemented before 30th June 2021. The assignment will be required 30 Working Days Level of Effort (LOE).

GEOGRAPHIC AREA

Selected firm/ individual will develop and work in consultation with the USP Pakistan team and deliver product CE Mark certification in selected PPE manufacturing facilities situated at Lahore, Sialkot, Faisalabad, Hyderabad, Karachi.

REPORTING

Selected firm/ individual will report to the PQM+ Deputy Chief of Party.

EVALUATION CRITERIA

  1. Past Experience - 30% 
  2. Qualification and Education - 30% 
  3. Financial Proposal- 40% 

IMORTANT NOTE:

The Consultant (Firm/Individual) is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.

Please send CV/Profile, 3-References, and Daily Rate by downloading following ANNEX – D (Template):

https://drive.google.com/file/d/1SNQftPHB25vpRZTcznnsDrFRB8d2r7d1/view?usp=sharing

The Quoted Per Day Rate should be inclusive of all applicable taxes, traveling and any other associated costs.

Kindly send all Technical and Financial Proposal to ATTN:  USP Pakistan Procurement at [email protected] before the closing date (April 14th, 2021). When submitting your application, write " CE-Mark-Certification for Products - Pakistan" in the email Subject Line.





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