- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- This position reports to the QC Coach and will be part of the Quality Organisation at our company.
- The Quality Control Specialist coordinates all quality control activities relating to product schedules including any project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.
- provide technical expertise, trouble-shooting, training and support to laboratory technicians.
- Ensures Quality Control readiness to support all scheduled activities, consistent with company's requirements to ensure compliance, safety and reliable supply to our customers.
Responsibilities include :
- Work as directed by Quality Lead according to Company safety policies, cGMP and cGLP. Required to drive compliance with company Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Facilitate and drive effective communication to ensure success. Facilitate / Attend tier meeting for QC function and other support functions as necessary ensuring that the relevant group representatives attend to confirm all testing and validation activities are on schedule. Liaise effectively with external groups such as External testing Labs, QS, stability hubs, etc.
- Provide oversight for the selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required.
- Ensure all external laboratory quality agreements are in place and adequately cover all applicable testing.
- Coordinate site stability activities, reviews and approves all product stability protocols, ensure all stability sample numbers are communicated to the relevant department. Ensures all in-house stability testing is reported out within the required time frames.
- Coordinate creation/ update to Quality standards for raw materials/ components and product.
- Completes impact assessments for Quality standard updates/ analytical change controls and shelf-life changes related to processes initiated by off-site change owners.
- Coordinates QC equipment projects including purchasing and ensuing validation. Coordinates any efficiency/ increased
- Lab capability projects as detailed by Quality Manager.
- Represent the QC Department on site/inter departmental projects.
- Acts as a SAP Master Data process steward to ensure all material inspection plans are created in accordance with material introduction schedules.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of the lab.
- Bachelors Degree or higher preferred in a related Science discipline
- 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 2 years’ experience in a similar role.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals,needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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