Biotech Vision Care
Role Objective:
A key objective of this profile is to supporting the validation team in the qualification of equipment processes and systems. The role involves assisting with validation activities to ensure compliance with regulatory standards and internal quality management systems.
Desired Candidate Profile:
Graduate or Post Graduate in Engineering or a Masters degree in Life Sciences or a related field.
Basic understanding of quality assurance and validation principles.
Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) is preferred.
Strong attention to detail with the ability to follow instructions precisely.
Good communication and teamwork skills.
Eagerness to learn and grow in the quality assurance and validation field.
Role & Responsibilities:
Support senior validation staff in performing Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) activities.
Assist in collecting data during validation activities and performing basic tests on equipment and processes under guidance.
Execute validation protocols for equipment processes and systems to ensure they meet industry regulations.
Assist in preparing validation documents such as protocols test plans and reports ensuring proper filing and maintenance of documentation.
Record test results deviations and corrective actions accurately and support the review of validation data.
Ensure validation documentation complies with internal standards and regulatory requirements.
Adhere to GMP GDP and internal quality management systems (QMS) while performing validation tasks.
Assist in ensuring compliance with FDA ISO 13485 and other relevant regulatory guidelines in validation activities.
Support the preparation of documentation for internal audits and regulatory inspections.
Participate in addressing audit findings or corrective actions related to validation processes.
Collaborate with crossfunctional teams including manufacturing engineering and quality assurance to assist in validation activities.
Attend training and meetings to enhance knowledge of validation processes and regulatory requirements.
Provide updates on assigned tasks and progress to senior validation staff.
Functional Skills Required
Basic understanding of validation processes (IQ OQ PQ).
Ability to interpret technical data and follow validation protocols.
Knowledge of regulatory guidelines such as FDA and ISO 13485 is advantageous.
Strong documentation skills with an understanding of GDP and GMP.
Proficiency in MS Office Suite (Word Excel PowerPoint).
Behavioral Skills Required
Detailoriented with a focus on accuracy and precision.
Ability to work effectively in a team environment.
Strong communication skills both written and verbal.
Eagerness to learn and develop professionally.
Ability to follow instructions and manage time efficiently.
collaboration,gmp,engineering principles,cad,risk assessment,communication,regulatory requirements,cad/cam,factory design utilities,gdp,design verification,inventor,training sessions,design,presentation,client interactions,quality,material properties,cad software,industry standards,problem-solving,manufacturing processes,ms office suite,technical demonstrations,product design & manufacturing collection,autodesk manufacturing software,technical drawings,fda,project management,validation,plm concepts,fusion manage,product design,fusion 360,regulatory guidelines,quality assurance,iso 13485,microsoft office
Trainee Officer QA - Mechanical
