Job Title: Senior QC + QA Trainer (Pharma / Biotech Laboratory)
Location: Remote
Job type: Part-time
Job Summary:
We are seeking a highly experienced and knowledgeable QC + QA Trainer to design, develop, and deliver technical training programs for quality control and quality assurance teams. The trainer will be responsible for building competence in analytical testing, documentation practices, GMP compliance, and QA/QC systems within a regulated laboratory environment.
Key Responsibilities:
Training & Development
Develop and deliver structured training programs on QC laboratory techniques, QA systems, and GMP compliance.Conduct practical laboratory training (analytical instruments, wet chemistry, microbiology as applicable).Train teams on Good Documentation Practices (GDP), Data Integrity (DI), and OOS/OOT handling.Prepare and update SOP-based training modules and competency assessments.Conduct refresher training, audits-based retraining, and new hire onboarding sessions.Technical & Quality Expertise
Provide hands-on training in HPLC, GC, UV-Vis, FTIR, Dissolution, Wet Chemistry, and analytical data review.Guide QA and QC personnel on Change Control, Deviation, CAPA, and Internal Audits.Ensure all training programs align with cGMP, GLP, ISO, and regulatory (USFDA, MHRA, WHO) guidelines.Support QA in documentation review, batch record review, and laboratory compliance.Training System Management
Maintain training matrices, records, and competency evaluation logs.Collaborate with QA Training/HR teams for periodic training plan updates.Perform gap assessments and recommend improvement actions.Participate in regulatory inspection readiness and training audits.Education:
M.Sc. / B.Pharm / M.Pharm / B.Sc. in Chemistry, Biochemistry, Microbiology, or related discipline.Experience:
Minimum 10-15 years total experience in QC and QA within the pharmaceutical/biotech/FMCG domain.Minimum 5 years of direct laboratory experience (analytical or microbiology lab).Prior training, mentoring, or internal trainer experience is preferred.Technical Competencies:
Strong knowledge of GMP, GLP, GDP, Data Integrity, QMS.Expert in analytical method validation, calibration, and documentation.Familiar with regulatory inspection observations (FDA, EU, WHO, MHRA).Proficient in root cause analysis, deviation management, CAPA systems.Soft Skills:
Excellent communication and presentation skills.Strong documentation and report-writing skills.Ability to coach and mentor multi-level teams.Proactive, detail-oriented, and organized approach to training delivery. Read LessJob Title: Senior Automation Engineer - Pharmaceutical Manufacturing
Location: Remote
Experience: 10+ years
Industry: Pharmaceutical / Biotech Manufacturing
Job Summary:
The Senior Automation Engineer is responsible for driving automation initiatives across pharmaceutical manufacturing systems, ensuring compliance with GMP, and enhancing equipment reliability and process efficiency. This role involves overseeing automation design, programming, validation, and maintenance of PLC, SCADA, and related control systems used in production and utility areas.
Key Responsibilities:
Managed automation systems supporting production, utilities, and cleanroom environments in compliance with GMP and regulatory requirements.Developed, modified, and optimized control logic for PLC, HMI, and SCADA systems (Siemens, Allen-Bradley, DeltaV, or equivalent).Supported the design, configuration, and integration of new automated equipment and systems into existing production lines.Performed troubleshooting and root cause analysis of automation and instrumentation failures to minimize downtime.Executed system upgrades, patches, and changes following change control procedures and validation standards (GAMP 5).Prepared and reviewed technical documentation including URS, FDS, FAT, SAT, IQ/OQ/PQ, and SOPs.Ensured data integrity and compliance with 21 CFR Part 11 for electronic records and automation systems.Collaborated with cross-functional teams (Engineering, QA, Validation, and Manufacturing) for project execution and continuous improvement.Guided junior engineers and technicians in automation programming, troubleshooting, and documentation practices. Read LessJob Title: Senior Trainer - Validation (CQV, Equipment, Injection Mold, HVAC)
Location: Remote
Job type: Part-time
Job Summary:
To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.).
Key Responsibilities:
Develop and deliver training modules on:Commissioning, Qualification, and Validation (CQV) lifecycleEquipment Qualification (IQ/OQ/PQ)Process Validation for Injection Molding MachinesHVAC system qualification and cleanroom validationDesign hands-on practical sessions, assessments, and workshops to enhance applied learning.Review and update training materials as per the latest regulatory and industry standards.Conduct competency assessments and provide feedback to trainees and management.Collaborate with validation, quality assurance, and engineering departments to align training needs with current and future project requirements.Support in developing SOPs, validation protocols, and templates for training use.Monitor training effectiveness using evaluation metrics (KPI / feedback analysis).Ensure all training complies with GMP, ISO, and EHS standards.Mentor junior validation engineers and guide them in real-time project scenarios.Key Skills and Competencies:
Strong knowledge of CQV methodologies, GAMP 5, Risk-Based Validation, and Change Control.Expertise in Equipment & Utility Qualification, Injection Molding Validation, and HVAC System Validation.Familiarity with regulatory frameworks: USFDA, EMA, WHO, ISO 13485, ISO 14644.Excellent presentation, communication, and technical documentation skills.Ability to translate complex validation concepts into practical training modules.Proficient in Microsoft Office, validation software, and data analysis tools.Educational Qualification:
Bachelor's or Master's degree in Mechanical / Electrical / Instrumentation / Industrial / Validation Engineering or related discipline.Additional certification in Validation / Quality Systems / Six Sigma (preferred). Read Less