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Location

Diu | India

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Job description

Greetings from Talisman HR Solutions!

We are looking for an experienced Quality Assurance individual to lead the Quality Assurance function through its staff, ensuring full and strict adherence and compliance to the cGMP, Policies, Procedures, and Prevailing local and international guidelines instilling quality in the heart of everything the QA Team does.

 

Industry- Manufacturing & exporting of Pharmaceutical Products based in India.

Designation- Manager-Quality Assurance
Qualification- B.Pharm/M. Pharm/M.Sc
Work Timings- 8.30 a.m. To 5.00 p.m.
Working Days- Monday to Saturday
Salary- Basis experience and caliber

Experience- Minimum 10 years

Designation:  QA Manager

Location: Daman

Reporting:  Plant Head

 

 

Essential Duties and Responsibilities:

• Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals
• Responsible for setting strategy direction for the Quality Assurance Dept. and team
• Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support (if any)
• Support team by guidance and coaching and provide direction/approval of activities and decisions
• Cultivate and reinforce appropriate group values, ethics, norms, and behaviors
• Share oversight to individuals and teams on personal development, performance, and quality-related issues. Write and deliver performance reviews
• Ensure proper use of assets, budget, and personnel and communicate effectively with key customers and partners, both within the site and outside as appropriate
• Responsible for supporting all planned and unplanned manufacturing and lab deviations, review and approval of product and equipment change controls (including SOPs and master batch records)
• Conduct impact assessment to design changes and participate in/coordinate the CAPA Review Board
• Maintain the structure to ensure all quality commitments and timelines are tracked and met. In addition, assist the senior leaders at the site in resource and budget preparations
• Responsible for driving process improvements within Drug Substance, Drug Product, and Site support systems
• Actively with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues
• Coordinate planned and ad-hoc external audits drive Internal Audit plans and share reports and outcomes to the Site Management Team proposing continuous improvement action plan
• Responsible for driving cross-training across Drug Substance, Drug Product, and Site staff resources (as well as potentially other areas of QA)
• Work directly with internal and external customers to ensure Best-in-Class expectations for quality are met if not exceeded
• Analyze trends, quality metrics, and other data to identify quality and compliance gaps
• Participates in the recruitment, selection, promotion, and performance management of QA employees.

Job Requirements

 

Qualification/Knowledge/Experience:  

Level of Education: Pharmacy graduate preferably with a related post-graduate QMS degree or

Experience:  Track record of leading the QA function at sound pharmaceutical organizations.

Language:  Excellent verbal, written, and interpersonal communication skills. English fluency essential

IT Literacy:  MS-Office

 

Competencies and Behaviors:

• Previous experience mentoring and coaching experienced Quality professionals
• Proven results using quality improvement tools and techniques to drive improvements across different functions.
• Leading by example to be a role model for others
• Collaborative approach and ability to build strong partnerships with cross-functional teams to drive results
• Demonstrate excellent communication, facilitation, and conflict-resolution skills
• The drive for self-development, the ability to collaborate, and an action-oriented work ethic
• Excellent written and verbal skills in English
• Project Management experience and certification is a definite plus

Interested candidates can share their CV on [email protected] Please share your current and expected package.

Quality Assurance,manufacturing support,cGMP,review and approval,master batch records

Designation: Manager-Quality Assurance

Vacancies: 1

Experience: 7.0 Year(s) - 10.0 Year(s)

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Job tags

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Salary

Rs 7 - 9 lakhs p.a.