Reviewer, Documentation Quality Control

Job purpose

The main responsibility of this position is to ensure through review of relevant documentation that all Taro products, bulk, finished goods, stability and raw materials and laboratory practices, meet the company and cGMP requirements before release for sale, manufacture or packaging.

Duties and responsibilities

• Review all laboratory related documents to ensure that Quality Control Laboratory: finished products, bulk, raw material stability, and Microbiology meet Taro and GMP requirements prior to release
• Review accuracy of data entries in BPCS and/or LIMS
• Contribute and generate reports / performance metrics and data
• Automates job functions to achieve efficiency improvements
• Works with other departments to proactively build quality into the processes and systems
• Complete all GMP Documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Participate in and/or lead Non Conformance Investigations
• Complete Corrective and Preventive Actions (CAPA’s)
• Initiate, and follow through with actions required to close Change Controls
• Participate in Internal, Customer and Regulatory Audits.
• Assist personnel with documentation issues and provides coaching and guidance to Quality Control team.
• May be required to deliver technical training programs.
• Participate in activities supporting Laboratory Investigations
• Provide support for Regulatory Inspections
• Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• B. Sc. (Chemistry or Microbiology) or equivalent experience is required
• Minimum5 years experience with quality control laboratory background in pharmaceutical industry
• Quality Assurance and audit background in pharmaceutical industry would be an asset
• Proficient knowledge of applicable instruments (HPLC, GC experience preferred)
• Multi-tasking ability
• Sound knowledge and application of Health Canada and FDA regulations
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
• Excellent written communication and report writing skills
• Demonstrated ability to apply analytical thinking, problem solving and detail orientation.
• Proficient knowledge of chemistry
• Excellent written and verbal communication skills
• Strong organizational skills to handle the high amount of documentation reviewed by this position
• Ability to work in a deadline-oriented environment

Working conditions

Generally the conditions are pleasant, not unlike normal office positions with fairly pleasant surroundings.  There are infrequent exposures to higher than normal noise levels (when visiting plant).  Mostly desk work with a mixture of standing and walking and some light lifting. Ability to work under stressful conditions and prioritize workload

Physical requirements

Office based

Direct reports

NA