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Quality Assurance Manager

We are seeking a dynamic and experienced Quality Assurance Manager to oversee Batch Manufacturing Records (BMRs), develop and maintain standard operating procedures (SOPs), ensure compliance with industry regulations, and lead our factory inspections by customer (pharmaceutical companies) inspection teams.

Key Responsibilities:

Supervise Batch Manufacturing Records (BMRs):
- Oversee the creation, review, and approval of BMRs to ensure accuracy and compliance with established procedures.
- Implement corrective and preventive actions based on BMR findings.
Standard Operating Procedures (SOPs):
- Write, amend, and oversee all SOPs related to the manufacturing of empty hard gelatine capsules.
- Ensure that SOPs are updated in accordance with industry standards and regulatory requirements.
Compliance Supervision:
- Monitor and enforce compliance with industry regulations, company policies, and quality standards.
- Collaborate with cross-functional teams to address and resolve compliance issues.
Factory Inspections:
- Lead and coordinate factory inspections by pharmaceutical companies' inspection teams.
- Work closely with various departments to prepare for inspections and address any concerns raised during the process.

Qualifications:

Pharm-D
Minimum of 5 years of work experience in the Quality Assurance department of a pharmaceutical company.
In-depth knowledge of industry regulations and quality standards.

Skills and Competencies:

Strong leadership and managerial skills.
Excellent communication and interpersonal skills.
Attention to detail and a commitment to maintaining high-quality standards.
Ability to collaborate with cross-functional teams and work under pressure.
Familiarity with regulatory requirements for pharmaceutical manufacturing.

If you meet the qualifications and are passionate about ensuring the highest standards of quality in pharmaceutical manufacturing, we invite you to apply for this opportunity.