ELVIS OPOKU BAAH
Leeds,Leeds
Summary
Highly skilled professional with a strong understanding of production processes according to GMP, FDA, and EMEA standards and extensive experience in aseptic manufacturing process and medical device regulations. Demonstrates exceptional manual dexterity, attention to detail, and the ability to work under pressure effectively. Proficient in quality control, batching processes according to SOPs, deviation management and CAPA's according company QMS. Known for a strong work ethic and the ability to work autonomously and within a team. Ability to search for improvement opportunities and apply new and creative solutions.
Overview
8
8
years of professional experience
9
9
years of post-secondary education
1
1
Certification
Work History
GMP Consultant
exFDA
Zurich, Zurich
01.2024 - Current
- Help companies get products approved and stay compliant over their lifecycles.
- Collaborates with variety of industry professionals for effective project delivery.
- Knowledge of regulatory requirements (FDA 21 CFR 820, MDSAP)
- Gap Analysis Medical device Iso13485
- Managed multiple projects simultaneously whilst ensuring timely completion and quality control.
Pharmaceutical manufacturing technician
Chiesi S.p.A
Parma, Parma
05.2023 - Current
- Cleanroom operator able to work in grade A and grade B
- Assisted engineers in setting up and validation of new machinery, resulting in increased production capabilities.
- Perform pH analysis on finished products.
- Adhere to ALCOA data integrity principles, ensuring accurate and reliable data management.
- Conduct compounding activities (aseptic manufacturing, both SCADA-controlled and manual).
- Perform aseptic filling operations using RABS and isolators.
- Participate in process deviation investigations alongside supervisors, contributing to root cause analysis (RCA) and definition of corrective and preventive actions (CAPA) in collaboration with QA.
- Maintain a safe work environment and have a strong cGMP mindset contributing to a culture of quality and compliance.
- Usage of SAP along with other digital systems for efficient data management and process tracking.
- Conducted training sessions for junior staff members to improve their technical skills and knowledge base.
- Demonstrated ability to work under pressure, often achieving tight deadlines without compromising on quality.
Manufacturing chemical operator
Arkema Srl
Boretto , Province of Reggio Emilia
07.2019 - 01.2020
- Operated machinery to mix, dispense and handle chemicals safely.
- Kept detailed records of process data for traceability.
- Ensured product quality by adhering to company standards and regulations.
- Mixing of primers for acrylic products
- Worked on assembly line, producing high-quality goods. (Bostik’s, coating resins, ecc.)
Manufacturing technician
Bormioli Luigi
Parma, Parma
06.2018 - 09.2018
- Ensured product quality by implementing rigorous checks at each manufacturing stage.
- Maintained clean working environment, promoting workers’ safety and productivity.
- Performed quality control and visual inspection to confirm finished products met production standards
- Supervised 8 work operators throughout production phases to ensure efficiency and compliance.
- Streamlined assembly processes to improve production speed and reduce errors.
Clinical laboratory technician
Parma Hospital
Parma, Parma
07.2017 - 09.2017
- Conducted complex chemical analyses for vital research outcomes.
- Assisted in routine lab operations, increasing overall productivity levels within the facility.
- Chemo-physical analysis of proteins, urine and blood at the Parma hospital
- Chemical, physical and microbiological analysis on milk (M.P.N. for Butyric Clostridia spores in milk, serum acidity (pH), CFU dead cells in milk, nutritional values
of milk samples, density, E.L.I.S.A. Aflatoxins) - Chemical and microbiological analysis of food and water.
- High performance liquid chromatography (HPLC for separation of 2 compounds in a solvent)
- Ensured safety protocols adherence, minimizing risk of contamination.
Education
Bachelor of Science - Biology
University of Parma
Parma 10.2019 - 07.2024
A-Levels - Health Biotechnology
ITIS PARMA
PARMA 09.2013 - 06.2017
Skills
- Qualitative research
- Outstanding verbal and written communication skills
- GMP (Annex 1), FDA, and EMEA compliance
- Aseptic Manufacturing & Sterile Processes
- Good time management and organisation skills
- pH Analysis & Quality Control
- Strong analytical and problem-solving skills
- cGMP Documentation & Batch Record Review
- IT literate ( MS excel , MS powerpoint , MS office)
- ERP Systems (SAP HANA) & Inventory Management
- Root cause analysis (5 why’s, Fishbone and FMEA)
Languages
Italian
Native
Spanish
Elementary
English
Native
Affiliations
- Reading
- Bass guitar playing
- Movies
Certification
- Biotility: Corrective Action Preventive Action (CAPA)- University of Florida- CITI program
- Lead auditor gmp (udemy ACCREDITATED)
Timeline
GMP Consultant
exFDA
01.2024 - Current
Pharmaceutical manufacturing technician
Chiesi S.p.A
05.2023 - Current
Bachelor of Science - Biology
University of Parma
10.2019 - 07.2024
Manufacturing chemical operator
Arkema Srl
07.2019 - 01.2020
Manufacturing technician
Bormioli Luigi
06.2018 - 09.2018
Clinical laboratory technician
Parma Hospital
07.2017 - 09.2017
A-Levels - Health Biotechnology
ITIS PARMA
09.2013 - 06.2017
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