Quality Assurance Associate

0081762 High quality Assurance Affiliate

Place Abstract

Catalent is a worldwide, high-growth, public firm, and a number one accomplice for the pharmaceutical business within the improvement and manufacturing of recent remedies for sufferers worldwide. Your skills, concepts, and keenness are important to our mission: to assist folks reside higher, more healthy lives. Catalent is dedicated to a Affected person First tradition by excellence in high quality and compliance, and to the protection of each affected person, client and Catalent worker.

Reporting to the High quality Assurance Supervisor (Operations), the High quality Assurance Affiliate (Operations) will create a tradition of high quality, compliance, and steady enchancment, which meets the federal government, buyer and enterprise necessities. The incumbent’s focus can be on prevention slightly than detection of high quality points. As well as, the function consists of teaching/coaching operators and supervisors on correct documentation practices on cGMP necessities.

This place is situated in Windsor, Ontario, one in every of two websites situated in Canada providing softgel improvement and manufacturing capabilities for the Pharmaceutical and Shopper Well being industries. We have now a broad vary of built-in formulation, manufacturing, analytical and packaging providers to supply full-service turnkey options.

Shifts: Continental Shifts (Days and Nights)

The Position

• Performs In-Course of Batch overview of documentation and ensures all product has been manufactured in compliance with cGMPs and SOPs. This consists of teaching/coaching of staff and supervisors on every concern, guaranteeing that every concern has been famous and that applicable actions are taken to handle the problem.
• Assists within the initiation of all manufacturing occasions and deviations as reported by the manufacturing departments. Ensures that each one product which has been recognized as doubtlessly having a high quality concern is suitable for launch, and the stories have been up to date accordingly.
• Performs line clearance verifications of apparatus and processing areas throughout changeovers from one kind of product to a different kind of product — might embody testing/verification of imaginative and prescient gear.
• Acts as QA consultant on shift in decision-making and concern decision, escalating critical points to manufacturing administration and QA administration as required.
• Points, critiques and information numerous logs from areas of operation — consists of gear log, Temp/RH logs, and many others.
• Displays GMP compliance within the working areas to help in sustaining inspection readiness.
• Participates in particular initiatives as required in different areas of high quality and compliance.
• Should be capable to work prolonged hours, weekends as wanted, particularly when issues happen or when deadlines have to be met and performs different duties as required.

The Candidate

• Bachelor’s diploma in science (Chemistry or Biochemistry most popular) is required.
• Expertise working in a producing, pharmaceutical and/or GMP facility is an asset.
• Superior laptop expertise in Microsoft Workplace Suite (Outlook, Excel, Entry, Phrase)
• Robust analytical expertise
• Extraordinarily detailed oriented
• Robust interpersonal expertise
• Wonderful communication expertise — verbal and written.
• In a position to work independently with minimal supervision.
• The worker is usually required to sit down and use their palms and fingers, to deal with or really feel and to govern keys on a keyboard.
• The worker is required to face, stroll, attain with arms and palms, bend, or twist, and to stoop, kneel, crouch or crawl and sometimes bend and carry <20kg.
• Imaginative and prescient talents required by this job embody shut imaginative and prescient. The worker is required to face for lengthy.

Why You Ought to Be part of Catalent

• Complete Profit Bundle (Well being, Dental, Imaginative and prescient, & Life Insurance coverage)
• Group Retirement Financial savings –Registered Pension Plan (RPP) with employer contributions.
• Paid Time Off Packages together with trip, banked time & private time.
• Worker Reward & Recognition packages.
• Alternatives for skilled and private improvement & progress together with tuition reimbursement.

Catalent presents rewarding alternatives to additional your profession! Be part of the worldwide drug improvement and supply chief and assist us deliver over 7,000 life-saving and life-enhancing merchandise to sufferers world wide. Catalent is an thrilling and rising worldwide firm the place staff work straight with pharma, biopharma and client well being firms of all sizes to advance new medicines from early improvement to scientific trials and to the market. Catalent produces greater than 70 billion doses per 12 months, and each can be utilized by somebody who’s relying on us. Be part of us in making a distinction. 

Catalent is dedicated to the well being and security of its staff, guests and the shoppers and sufferers we serve. On account of the worldwide pandemic, now we have modified a lot of our recruitment and on-boarding processes to take care of everybody’s security. The Human Sources groups will talk all vital security processes and procedures all through every stage.

private initiative. dynamic tempo. significant work.

Go to Catalent Careers to discover profession alternatives.

Catalent is an Equal Alternative Employer and doesn’t discriminate primarily based on any attribute protected by native legislation.

Should you require cheap lodging for any a part of the applying or hiring course of as a consequence of a incapacity, you could submit your request by sending an e mail, and confirming your request for an lodging and embody the job quantity, title and site to [email protected]. This feature is reserved for people who require lodging as a consequence of a incapacity. Info obtained can be processed by a U.S. Catalent worker after which routed to a neighborhood recruiter who will present help to make sure applicable consideration within the software or hiring course of.

Discover to Company and Search Agency Representatives: Catalent Pharma Options (Catalent) isn’t accepting unsolicited resumes from companies and/or search companies for this job posting. Resumes submitted to any Catalent worker by a 3rd social gathering company and/or search agency and not using a legitimate written & signed search settlement, will develop into the only real property of Catalent. No price can be paid if a candidate is employed for this place because of an unsolicited company or search agency referral. Thanks.

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