Company Description
In 1999, Blaine established its toll/manufacturing arm, REFAMED RESEARCH LABORATORY CORPORATION, to give customers all the benefits of customized quality products. RRLC is a Certified ISO 9001:2008, GMP Certified, globally competitive Philippine based company that incessantly invests in research and technology geared towards the development of animal health & nutrition including contract manufacturing. We produce and market world-class products including veterinary preparations, feed concentrates, additives, and premixes, anchored solidly on the principles of manufacturing integrity utilizing only the best & reputable ingredients available in the market today.
In 2008, Blaine formed its Food Division into BLAINE FOOD CORPORATION, a food raw materials provider and product development/customization. BFC is dedicated to serving the food industry through our adherence to robust and highest standards of Manufacturing Services & Marketing of specialty ingredients, nutritional premixes, flavor compounds, spice, and seasoning blends intended for different food applications. Our dedicated staff has more than 40 years of combined experience in production, quality assurance, research and development, including sales and marketing. Our HALAL certified plant allows us to serve a wide range of markets, both local and international.
Likewise, in 2008, Blaine solidified its business of providing raw materials to the cosmetics, pharmaceutical, personal, and home care industries through the creation of BLAINE PERSONAL AND HOME CARE CORP. BPHCC is committed to providing impeccable products and services that allow its customers to receive maximum benefits in terms of performance and profitability.
Job Description
Job Scope:
Investigation and identifying the right root cause.
Provide analytical and technical skills to maintain company quality services and products.
Manage and supervise quality control laboratory activities.
Supervise and lead staff.
Ensure robust testing procedures and outputs and identify mistakes or non-conformity issues.
Duties & Responsibilities:
Develop procedures by understanding customer requirements to have effective quality control.
Ensure material and product specifications are in place for suppliers and monitor compliance.
Collaborate with Quality Assurance personnel for the implementation of systems, procedures, and standards of operation to comply with company standards and local regulations.
Lead the establishment and implementation of procedures for sampling, recording, and reporting data.
Supervise and guide all laboratory personnel to ensure quality in the process by which products are manufactured.
Final approver for all GxP documents.
Designated/alternate authorized person for batch release.
Appraise customer requirements and ensure satisfaction.
Facilitate proactive solutions by collecting and analyzing quality data.
Review and ensure all standards and policies are current.
Keep records of quality reports, statistical reviews, and relevant documentation.
Ensure that Out of Specifications are investigated and resolved.
Ensure appropriate actions are taken in case of willful or negligent GMP violations, escalating to responsible management for any necessary disciplinary action.
Ensure all legal standards are met to maintain certifications of the laboratory.
Ensure appropriate and timely escalation for quality-related matters.
Assess the conclusions of periodic reviews of process performance, product quality, and the Quality Management System.
Monitor the effectiveness of quality systems, including performance of GMP and internal audits, metrics monitoring, and participation in management reviews.
Lead, initiate, or participate in any process improvements aimed at improving efficiency and savings.
Ensure appropriate interface with authorities for any GxP-related activities.
Make decisions on withholding products from distribution if needed, for resolution of quality or compliance issues, or mandate market actions, up to and including recommendation for recall of product, following the relevant procedures.
Escalate any issues due to inadequate resources (personnel, budgetary, etc.) to perform quality oversight or duties.
Work collaboratively with other departments for completion of investigations through root-cause analysis pertinent to product/customer complaints and other related non-conformities identified within the process in coordination with the department head.
Prepare and submit departmental monthly/quarterly KPI and other reports on a timely basis.
Act as lead and representative of Quality Control for all regulatory and client audits and prepare necessary aids for external audits.
Facilitate the Quality Council Meetings and be responsible for the oversight of product quality and GMP compliance for all products manufactured or distributed from the site.
Qualifications
Education:
Graduate of B.S. Chemistry, Chemical Engineering, Pharmacy, and other science-related courses or more than 10 years of appropriate work experience.
Years of Related Work Experience:
With at least ten (10) years of relevant work experience.
Job Skills/Competencies Required:
Must be responsible, hardworking, honest, and trustworthy; with good exposure and in-depth knowledge in quality control procedures and systems; knowledgeable in the technical aspects of materials, intermediates, and finished products; aggressive and result-oriented; can work under pressure and be very flexible if time requires; must be computer-literate.
Excellent organizational and leadership abilities. Outstanding communication skills with strong attention to detail and a result-driven approach. Demonstrate knowledge of data analysis/statistical methods.
Others:
Hardworking and willing to work extended hours; operation may require good interpersonal and communication skills; must be responsible, hardworking, honest, and trustworthy; must be proactive; can work under pressure and longer hours; reliable and trustworthy.
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