Primary Responsibilities

Performs review and approval of data based on document review in a timely and effective manner according to methods, instructions, procedures, good laboratory documentation practices (GDP), good manufacturing practices (GMP) and standard operating procedures (SOPs).

Follow Training SOP for training and training records.

Specific Responsibilities

Document review and compliance

• Assures that reviewed QC records are compliant to methods, specifications and company’s applicable Standard Operating Procedure.

• Ensures that documentation review is complete in every respect and verify that all results entered the electronic laboratory information system LIMS.

• Assures records of Validation/Method Transfer/Verification and reports are as per protocol and method provided by clients or written by THE COMPANY. Assures method development records are reviewed as per THE COMPANY SOPs.

• Ensures test results are reported appropriately on either a CofA or a RofA depending on the validation/transfer status of the method.

• Audits all record books (logbooks), calibration related documents, and other QC documents, associated with testing, reviewed / approved.

Deviation and Out-of-Specification (OOS) Management

• Requests deviation to be reported or issues a deviation report in case where method or SOP was not followed as written.

• Informs analyst or his/her supervisor to initiate out-of-specification and/or issue OOS form in case of OOS, which was not noted by analyst.

• Issues an audit form noting deficiencies to method and procedures, returns the form to analyst for correction according to Data Review SOP. Ensures that all valid deficiencies are corrected, escalates all concerns to management.

Training and Development

• Incumbents are responsible for their own training records according to training SOP.

• Attends training sessions and ensures that training binder is current. Has a training record for every SOP version executed, if applicable. Requests training if work assigned requires knowledge of SOP

Quality and Process Improvement

• Revises forms for execution of methods and procedures; issues CCR for method change and new worksheet generation.

• Identifies, participates in and sometimes leads operational improvement initiatives.

• At all times, complies with THE COMPANY Code of Integrity and Professional Conduct. Remains familiar with THE COMPANY quality assurance procedures. Complies to all THE COMPANY QHSE and HR policies and procedures.

• Performs other related duties as may be assigned either in support of departmental goals or for his/her personal or professional training, education or development as programmed by his/her immediate superior.

Profile

• Minimum Bachelor of Science degree in Chemistry or Microbiology or related science discipline is required, M.Sc is preferred.

• Minimum 2 years’ experience working in a pharmaceutical laboratory or company is required.

• Demonstrated understanding of cGMP regulations is required. Knowledge in compendiums such as USP, EP preferred, JP, BP are advantageous.

• Experience with LIMS, TrackWise Digital or any other QMS system is advantageous.

• Proficiency in Microsoft Office Suite (Word, Excel, and Outlook) is required.

Required Skills

• Strong written and verbal communication skills in English (B2+).

• Proven ability to manage and coordinate multiple projects in a fast-paced, professional environment.

• Proven time management skills and proficient in effectively prioritizing tasks to meet deadlines set by Supervisors.

• Detail-oriented with the ability to identify minor discrepancies.

• Able / willing to learn new skills (review of new tests, instrumentation and procedures) as required.

• Thorough knowledge of scientific principles pertaining to analytical records reviewed. Ability to interpret, analyze data and draw logical conclusions required.