Quality Assurance Head

4 weeks ago

ahmedabad, India Synergy Resource Solutions Full time

Greetings from Synergy Resource Solutions, a leading HR Management Consultancy Firm.

Our client Company engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market. Their vision is to deliver high quality products at affordable prices by leveraging global partnerships with the best FDA approved manufacturing facilities across the world. They established in 2009, their head office in California.

Job Position : Senior Manager -Quality Assurance

Office Timing: 9pm to 6am

Weekdays 5 days

Location : Ahmedabad

Experience OSD knowledge compulsory

Min 15 years experience is compulsory

Recent UDFDA audit compulsory

Requirement:

The candidate's responsibilities include the hands-on execution of various critical tasks in the Quality Assurance Group. The successful candidate is a leader, self-driven, works with minimal direction and has well-rounded experience in previous Quality Assurance roles. This position will also establish, review and approve key quality system-related documents and ensure continuous compliance at company.

Responsibilities:

  • Develop and implement comprehensive quality strategies to ensure the consistent production of high-quality solid oral dosage form
  • Enforce GMP compliance
  • Ensure that all products meet regulatory requirements
  • Manage the quality assurance team
  • Establish and maintain a robust documentation system, including standard operating procedures (SOPs), work instructions, and quality records.
  • Monitor and analyze quality data, conducting trend analysis and initiating appropriate corrective and preventive actions (CAPAs) to address any deviations or non-conformities.
  • Review and approve internal and external Deviations, change controls, CAPAs, and OOS
  • Work closely with the regulatory affairs department to ensure quality and compliance issues related to customer complaints, adverse events, quality events, market recalls, and pharmacovigilance reporting
  • Prepare for FDA audits
  • Lead FDA audits
  • Perform 3rd party vendor audits. Vendors including contract manufacturing organizations, 3rd party logistics, contract research organizations, contract research laboratories, API manufacturers, raw material suppliers, primary/secondary packaging material supplier
  • Review and approve the finished product certificate of analysis
  • Release commercial consignments
  • Review data logger associated with temperature and humidity exposure for finished good consignments
  • Provide training and guidance to employees on quality systems, procedures, and best practices to ensure a culture of quality awareness and compliance.
  • Identify training needs and develop training programs to enhance the skills and knowledge of the quality assurance team.
  • Communicate effectively with internal stakeholders, management, and external parties regarding quality-related matters, including deviations, investigations, and corrective actions
  • Implement a risk management framework to identify and mitigate potential quality risks associated with the manufacturing processes, products, or regulatory requirements.
  • Conduct risk assessments, develop risk mitigation strategies, and monitor the effectiveness of implemented controls.
  • Oversee the review and approval of batch manufacturing and testing records, ensuring compliance with specifications and regulatory requirements.
  • Conduct periodic reviews and audits to identify areas for improvement and ensure continuous compliance with quality standards.
  • Other responsibilities as assigned by the supervisor
  • Domestic as well as international travel as required

Qualification:

  • Experience in generic pharmaceutical development with a good understanding of the solid oral drug development process
  • Strong knowledge of regulatory requirements for solid oral dosage forms
  • Expert knowledge of cGMP, ICH, USP, and FDA quality guidelines and regulations
  • Effective oral and written communication skills.
  • Candidates Having US B1/B2 is preferred

Benefits

  • Joining Bonus
  • Diwali Bonus
  • Health Benefits
  • PF
  • Team Outing
  • Training will be provided

If you meet the above qualifications, please submit your resume at

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