Job Opportunities at Chris Ejik Group of Companies

Responsibilities

• Develop, review and implement Analytical Testing Procedures (ATPs) and related documentation (eg SOPs) for regular and special starting materials, packaging materials, intermediates and finished products.
• Handling and use of the instruments in Instrumentation laboratory.
• Perform efficient physico-chemical analysis and evaluation on water samples, raw, and intermediate materials, finished products, stability studies and products undergoing Research & Development, returned products, etc., in accordance with Quality policy requirements and other international compendia (USP, BP, Ph Eur. etc).
• Apply material safety data sheet for all materials and products in use and ensure adherence to all HSE directives on the use of work equipment, environment, tools, materials and products to forestall occupational hazard due to handling and exposure during material sampling and testing.
• Preparation, standardization and documentation of volumetric solution and other analytical reagents to ensure testing accuracy and reliability.
• Participate in analytical methods validation and development of new product formulation.
• Stability testing of products for new formulations and ongoing stability trials, using physical and instrumental techniques as appropriate.
• Write analytical specifications using current pharmacopeias and review existing analytical specifications.

Requirements

• Minimum Educational Requirement: B.Sc Degree in Chemistry or Biochemistry or Physical Chemistry.
• 2 - 3 years relevant experience
• Knowledge of the principles and practice of Quality control & laboratory.

Competencies:

• Good knowledge of CGMP and GLP.
• Good Interpersonal relationship and communication.
• Data gathering, collation and analysis.

go to method of application »

Responsibilities

• Lead root cause analysis and corrective and preventive actions for audit observations, product complaints, product non-conformances, in-process deviations issues related to process controls
• Review completed batch records and other cGMP documents to ensure accuracy and completion in accordance with cGMP regulations
• Write, review and modify, as needed, SOPs for compliance with appropriate regulations
• Prepare/revise operating procedures and specifications
• Review/approve routine change control requests, deviation, quality risk assessment as designated
• Review and approve suppliers / service providers including supporting with audits of critical suppliers where required
• Monitor and ensure that batch records are audited per manufacturing/packaging/shipping requirements, when required.
• Lead and perform data review audits (Batch Production Records, Validation Documents and Development Documentation, Quality Control Data as required)
• Document non-compliance and evaluate if further investigation is needed
• Document results of deviation and complaint investigations, analysis, corrective actions and preventive actions
• Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.)
• Assist in incident investigation and reporting
• Assist in preparation and reviewing of key quality documents like SMF, Quality manual, Validation Master Plan, protocols and report

Qualifications

• Bachelor's Degree in Biological Sciences, Chemistry or related discipline, or equivalent relevant cGMP work experience.
• Minimum of 2 years relevant pharmaceutical industry experience in a cGMP environment
• Ability to comply with all good manufacturing practices (GMPs) regulations and follow all standard operating procedures (SOPs).
• Proficiency with Microsoft Office suite with emphasis on Word and excel
• Knowledge of tools, concepts and methodologies of QA
• Solid experience in effective usage of data analysis tools and statistical analysis
• Ability to multitask and manage time effectively to ensure all work streams are managed.
• Must possess excellent communication skills
• Abilityto solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.