Our client is in the Manufacturing industry currently recruiting an Assistant Quality Control Manager
The Quality Control department is responsible for supporting the Manufacturing department and external customers. The primary functions of the laboratory are raw material, in-process, finished product and stability testing. Laboratory testing encompasses assays performed on raw materials and drug product at various stages to determine product safety and quality.
This position reports to the Managing Director and is responsible for activities relating to the daily function of the Quality Control laboratory and strategic planning for the laboratory and laboratory staff. The individual is the subject matter expert on analytical testing.
The individual is heavily involved in partner and regulatory audits, site meetings, site-wide improvement projects, budgeting and data review and interpretation, including protocols, investigations, and laboratory documentation.
This QC Manager is responsible for the entire laboratory team, and is required to perform staff management duties such as reviews, disciplinary action, and ensure training is performed. The individual operates with very limited supervision and must be able to work both independently and on teams.
- Embrace a “team” working environment focused on achieving department goals by demonstrating willingness to accept assignments not specifically listed in the job description as allowed by the limitations of training, experience, and/or education.
- Adhere to safety rules and awareness, demonstrate good safety practices at all times. Take initiative to report and correct safety hazards. Use Personal Protective Equipment (PPE) associated with assigned tasks.
- Demonstrate and promote the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- Execute against project plans and goals as assigned by Quality Management.
- Meet productivity, quality and teamwork metrics for the level.
- Perform all assigned tasks according to applicable internal written procedures.
- Follow strict good documentation practices in line with company SOPs and cGMP regulation.
- Actively complete assigned training activities and document training within assigned time frames.
- Function as a subject matter expert within the analytical laboratory and provide support at all times.
- Monitor laboratory resources, identify/report resource gaps, and assist in recruiting, screening, procuring, and/or qualifying needed resources.
- Maintain utmost level of confidentiality at all times
- Write, revise, review, and implement technical documentation including protocols, reports; reference standard qualification reports; analytical test procedures; and change controls.
- Review analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and procedures/protocols.
- Review and/or write technical reports, procedures, investigations and protocols.
- Provide problem solving skills to support the resolution and documentation of investigations for laboratory and manufacturing issues.
- Draw conclusions from data and communicate those conclusions is writing.
- Determine root causes of non-conformance and recommend corrective action and ensure timely closure of investigations.
- Document, develop and apply strategies to ensure achievement of analytical objectives by monitoring/ evaluating the completion of tasks.
- Establish policies, procedures, and practices associated with laboratory activities including safety, testing, scheduling and documentation.
- Maintain and improve GMP compliance and documentation.
- Schedule laboratory testing and associated activities to minimize operational disruptions to departments.
- Perform annual review of data generated by the Quality Control Laboratory and generate data, figures and trends.
- Perform internal audits of Quality Control systems.
- Perform external audits of vendors with respect to cGMP’s.
- Determine and maintain laboratory budget.
- 3-4 Years working in a pharmaceutical manufacturing set up.
- Working familiarity with Good Manufacturing Practice a must.
How to Apply
Please send your CV to email@example.com