Manager-Quality Assurance

Posted Yesterday
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Mumbai, Maharashtra
Senior level
Software • Biotech • Pharmaceutical
The Role
Oversee quality assurance processes in the pharmaceutical industry, ensuring compliance with regulatory standards and managing quality management systems. Identify and solve quality issues through tools like RCA and FMEA. Collaborate with suppliers and lead teams in auditing and compliance efforts while promoting data integrity.
Summary Generated by Built In

Job Description:

Key Technical Skills:

• Regulatory Knowledge regarding cGMP, FDA regulations, ICH guidelines, and other applicable standard like EU GMPs
• Quality Management Systems (QMS)
• Equipment calibration, maintenance, technical know-how of utilities

• Supplier management
• Auditing and Compliance
• Root Cause Analysis (RCA): Understanding and applications of tools such as A3 PPS, 6 M/Cause and effect analysis/ fishbone diagrams, 5 Whys, fault tree analysis, or other RCA methodologies
• Quality Risk Management: Applications of QRM, and its implementation including tools such as FMEA (Failure Mode and Effects Analysis) and risk matrices
• Hands on experience of Electonic systems
• Data Integrity: Ability to detect and handle data integrity issues as per the regulatory expectations

Key Behavioral Skills:

Effective communication.
Collaboration and Teamwork
Problem-Solving
Leadership
Resilience
Critical thinking

Qualification/ Exposure/ Industry Experience

Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.

12-15 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

Preferred Skills:

Laboratory compliance
SCADA/DCS operations
Lab information management system

Location:Ferring India Production

Top Skills

Cgmp,Fda Regulations,Ich Guidelines,Eu Gmps,Qms,Fmea
The Company
HQ: St-Prex
5,940 Employees
On-site Workplace
Year Founded: 1950

What We Do

Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries.

Community guidelines available here: https://re.ferring.com/Ferring-LinkedIn-Community-Guidelines

Social Media Privacy Notice available here: https://www.ferring.com/social-media-privacy-notice/

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