Responsibilities include but are not limited to:
- Be cost effective and vigilant of laboratory purchases to ensure department is within the Revenue and Capex Budget as per spent analysis project.
- Provide feedback to management with laboratory standard hours for financial prudence in resource planning, allocation and manpower to ensure within approved budgets while building best in class quality processes and systems at site.
- Execute and maintain quality system controls to ensure no critical and major market complaints.
- Take appropriate steps to reduce waste and losses in the analysis process and build improved efficiency.
- Responsible for QC Data review and trending to ensure integrity and adherence to standard operating procedures and cGMP’s.
- Responsible for the compilation and interpretation of QC Analytical data including OOS and Microbiology for applicable Annual Product Reviews.
- Responsible to draw conclusions from real-time data and statistical reports.(if available)
- Responsible to ensure that established testing control procedures are followed.
- Responsible to ensure good documentation practices are followed.
- Maintain compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA.
- Communicate with Supervisor and/or report any preparations or data that may result in an incidence and out-of-specification (OOS).
- Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits.
- Maintain accurate and complete test records.
- Maintain current knowledge of regulatory and industry standards, trends and advancements.
- Review technology transfer of analytical methods and cleaning validations for new products.
- Assist in the monitoring of changes in the monographs Pharmacopoeia requirements, Regulatory agencies recommendations and implement the same in QC Lab.
- Review deviations, tasks and CAPA for Lab failures in OOS.
- Review departmental change controls as assigned.
- Review results of lab investigations when test results fall outside pre-established specifications (OOS) as assigned.
- Prepare in timely fashion updating and revision of SOP, specification, STP and any other document.
- Review of equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
- Establishes good working relation with contract laboratories.
- Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
- Prepare in timely fashion updating and revision of SOP, specification, STP and any other documents.
- Review completion of Tech Transfer of Finished products
- Prepare QC Data Review metrics as applicable.
- Ensure during review that all equipment is calibrated.
- Perform the Training Tracking Tool/Software for Quality Assurance and Quality Control.
We are actively seeking a Quality Control Chemistry Data Review Analyst. The QC Chemistry Data Review Analyst position supports the Quality Control group to maintain process optimization and manufacturing activities. The Data Review Analyst is a highly motivated member of the Quality Control (QC) Lab at the manufacturing facility, reporting to the QC Director, Chemistry. Primary responsibilities for this position will be the data review function of QC testing within the Quality Control laboratories and select third party laboratories plus the QC data compilation for Annual Product Review Reports associated with Glenmark marketed products in accordance with company and government regulations.
- Bachelor’s degree in Chemistry, or closely related scientific discipline.
- Degree in Chemistry is highly preferred.
- Minimum of five (5) years in the field of Pharmaceutical (manufacturing facility).
- Background in the functional areas of Quality Control in stability, finished product and raw material testing.
- Basic understanding of cGMP’s, cGLP’s, FDA regulations, and industry guidelines, as well as international regulatory guidelines. <li Knowledge in general laboratory equipment including but not limited to: HPLC, GC, UV-Vis and FTIR.
Knowledge & Skills:
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Strong organizational, analytical, troubleshooting and problem-solving skills.
- Ability to analyse details and perform structured decision-making on a daily basis.
- Excellent verbal and written communication. Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System) is a plus.
- Knowledge of cGMP, Regulatory guidelines, Compendial testing (USP), Internal auditing.
- Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices.
- Technical writing skills to generate SOPs and serve as the Subject Matter Expert.
- Support the Management to organize and maintain the QC team, good communications skills, front runner, and cGMP trainer.
- Must have worked in Regulatory environment.
- Will be an added advantage if the individual has dealt with multiple audits personally.