QC Lab Manager
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
Building on over 35 years of research and development, with over 4,500 licenses registered worldwide, Chanelle Pharma is headquartered on an 18-acre campus in Loughrea, Co Galway, with three manufacturing facilities, four research and development laboratories and a fifth R&D laboratory in Jordan. The company employs 550 people in Ireland, UK, Jordan and India. At Chanelle Pharma our employees drive our success and you will have the opportunity to collaborate in our diverse and inclusive environment, the ability to learn and grow in your career, and an opportunity to make a direct impact on our business and customers.
Chanelle Pharma has a proven track record of innovation and makes a significant investment in R&D annually and has doubled its sales growth in the last 5 years.
In 2018, the company announced an €85 million investment, the single largest investment by any Irish owned company, to double manufacturing capacity, launch 96 new products and grow its workforce to 850 people over a period of 5 years. As part of the investment, Chanelle opened a purpose built €10 million manufacturing facility in 2018 for the company’s expansion plans into the US market. The facility received FDA approval in September 2019.
Chanelle Pharma is on an ambitious growth trajectory and expanding its workforce across a number of disciplines in science, engineering, quality, finance, sales and marketing. The company won 2018 Pharma Company of the Year and Industry Company of Year, the first indigenous Irish company to win the award.
To co-ordinate and manage the laboratory activities to meet the requirements of the EU Guide to Good Manufacturing Practices (GMP) and current Health & Safety regulations. Overall responsibility for the raw material and finished product testing at Chanelle Pharma Loughrea.
This is an opportunity to be a part of a dynamic team within the Quality Control function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers
In this role you will report to the Head of Quality
- Ensure completion of testing to allow for timely release of raw materials, in process and finished product in line with production requirements, release schedules and customer requirements.
- Ensure timely review and approval of laboratory results, protocols, reports, SOP’s and other documentation as appropriate.
- Ensure that the analytical laboratory operates in compliance with cGMP requirements.
- Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate.
- Provide assistance to the Qualified Person’s in the role of performing product disposition.
- Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory
- Ensure timely completion of method transfer activities in accordance with relevant procedures.
- Ensure timely completion of Cleaning Validation analysis and protocol review
- Assist the Head of Quality in represent the laboratory during Regulatory inspections and Customer audits.
- Ensure that corrective actions identified as a result of observations raised during regulatory & customer audits are implemented in a timely manner.
- Ensure that all GMP related documentation is regularly reviewed and updated in accordance with Company policy.
- Review and approve company standard operating procedures.
- Ensure that product quality review reports are prepared by the laboratory personnel in a timely manner.
- Conduct external audits of vendors, contract laboratories and contract manufacturers as appropriate.
- Assist in the appropriate selection, approval and on-going monitoring of contract laboratories is performed.
- Assist in the review of Technical Agreements with contract laboratories behalf of Chanelle.
- Provide details on Key Performance Indicators (KPI’s) to reflect the performance of the Laboratory function.
- Carry out performance reviews with Laboratory personnel in accordance with the Company performance management system.
- Identify training and on-going development opportunities for laboratory personnel.
- Ensure that training records are maintained.
- Ensure that continuous improvement initiatives are identified and implemented in the laboratory as appropriate.
- Assist in the selection and recruitment of Laboratory personnel in conjunction with Human Resources.
- Monitor the laboratory capacity to ensure that the resources meet the requirements of the business and take appropriate corrective measures as required.
- Ensure the laboratory operates within the requirements of the budget on a monthly basis.
- Participate in initiatives with suppliers of laboratory consumables, contract laboratories & service providers on a regular basis to negotiate pricing and to incur cost savings.
- Lead by example ensuring that your work area is kept tidy and that GLP/GMP standards are adhered to at all times
- Display key behaviours
- Establishes strong working relationships with others, building team rapport and creating a cohesive team environment
- Displays a positive outlook with strong coaching skills, maintaining interest at all times
- Takes a methodical, systematic and structured approach to organising work
- Makes effective and consistent decisions in a timely manner
- Takes a personal reasonability for making a decision, taking action within their own area
- Escalates issues appropriately
- Takes action to correct poor performance by being fair and consistent in approach
- Displays flexibility, willingness to succeed and goes the extra mile
- Knowledge in analytical techniques (Such as HPLC, GC, IR, and various wet chemistry techniques)
- > 10 years of experience in the laboratory as per GMP requirements
- Good verbal and written communication skills and the ability to work independently in analytical; environment
- Good computer skills with Word, Excel and any other statistical programs
- Knowledge of Process and Cleaning Validation
- Abel to conduct internal and external regulatory audits
PHYSICAL DEMANDS: Health & Safety requirements
- To take reasonable care for their own safety, health and welfare at work and that if aby other person that may be affected by their actions or omissions while at work
- To cooperate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions
- Adheres to safety regulations by ensuring correct usage of PPE in the lab area
- Reports to the supervisor or health and safety representative without unreasonable delay of any defects in plant, equipment, place of work, system or work which might endanger safety, health or welfare of themselves or any employee, contractor or visitor to the company
- Keeps work area safe, clean and tidy
- Required Training
- Manual Handling Training
- Glove Removal and Disposal Training
- Working with Chemicals
- Disposal of Waste
- Working on PC
- Sc. / M.Sc. in Scientific Discipline
- HPRA / USFDA Experience
- 5+ years Management experience, with at least 5 years in pharmaceutical industry incorporating QC and QA experience, production experience would be advantageous.
- Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management
- Proactive, motivated, analytical and strategic thinker.