Quality Specialist

1 month ago

india PSC Biotech Ltd Full time
Job Description

About PSC Biotech

 

Who we are?

 

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

 

‘Take your Career to a new Level’

 

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

 

Employee Value Proposition

 

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.


Job Purpose:

The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities at the client site.


Requirements

Key Result Areas and Primary Activities:

·        Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.

·        Perform and review complaints and deviation investigations, change controls and CAPA’s.

·        Creates and maintains assigned SOPs.

·        Compiles data for reports and presentations, provides data interpretation draws conclusions.

·        Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.

·        Support product recalls and stock recoveries as appropriate.

·        Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.

·        Identify compliance gaps and make recommendations for continuous improvement.

·        Assists in the induction process for new starters and training of other staff.

·        Generally, follows standard procedures and consults with manager/supervisor on exceptions.

·        Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.

·        Keeps abreast of cGMP requirements as described in applicable worldwide regulations.

·        Represents department on cross functional teams.

·        Additional activities as assigned by the manager/supervisor.

 

Skills Required:

·        The Specialist is required to possess a degree in a Science or Engineering discipline plus some industrial experience.

·        Alternatively, they must possess considerable industrial experience.


#LI-PM3
Requirements
Key Result Areas and Primary Activities: · Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification. · Perform and review complaints and deviation investigations, change controls and CAPA’s. · Creates and maintains assigned SOPs. · Compiles data for reports and presentations, provides data interpretation draws conclusions. · Completes audits to ensure compliance to SOPs, GMPs and applicable regulations. · Support product recalls and stock recoveries as appropriate. · Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review. · Identify compliance gaps and make recommendations for continuous improvement. · Assists in the induction process for new starters and training of other staff. · Generally, follows standard procedures and consults with manager/supervisor on exceptions. · Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements. · Keeps abreast of cGMP requirements as described in applicable worldwide regulations. · Represents department on cross functional teams. · Additional activities as assigned by the manager/supervisor. Skills Required: · The Specialist is required to possess a degree in a Science or Engineering discipline plus some industrial experience. · Alternatively, they must possess considerable industrial experience. #LI-DM2

  • Data Quality Specialist

    2 weeks ago

    india 2coms Full time

    Job Description This is a remote position. Looking For Data Quality Specialist Professionals For Global IT MNC. Greetings from 2COMS Group! Location - Remote Experience: 3+ years Must Have Skill:- Data Quality Specialist. Good Comm skill is mandatory.Requirements Looking For Data Quality Specialist Professionals For Global IT MNC. Greetings from...

  • Data Quality Specialist

    4 weeks ago

    india 2coms Full time

    This is a remote position. Looking For Data Quality Specialist Professionals For Global IT MNC. Greetings from 2COMS Group! Location - Remote Experience: 3+ years Must Have Skill:- Data Quality Specialist. Good Comm skill is mandatory.

  • Data Quality Specialist

    3 weeks ago

    india 2coms Full time

    This is a remote position. Looking For Data Quality Specialist Professionals For Global IT MNC. Greetings from 2COMS Group! Location - Remote Experience: 3+ years Must Have Skill:- Data Quality Specialist. Good Comm skill is mandatory.

  • Quality Assurance Specialist

    3 weeks ago

    india Indsource International Full time

    Company Description Indsource International is a leading Buying House based in Gurugram, India. We specialize in home, lifestyle, and fashion products including softlines such as textiles for home, bath, kitchen, and floor, as well as hardgoods like handicrafts, lamps, furniture, and decoratives in various materials. We ensure a smooth and buyer-friendly...

  • Quality Assurance Specialist

    3 weeks ago

    india Snaphunt Full time

    The Offer Work in a company with a solid track record of performance Join a well known brand within Hospitality Flexible working options The Job Your responsibilities will include: Test, inspect, and audit meat products, recipes, and website content – using various methods and tools, such as sampling, tasting, checking, and reporting Ensure that...

  • Quality Assurance Specialist

    1 month ago

    india Snaphunt Full time

    The Offer Work in a company with a solid track record of performance Join a well known brand within Hospitality Flexible working options The Job Your responsibilities will include: Test, inspect, and audit meat products, recipes, and website content – using various methods and tools, such as sampling, tasting, checking, and reporting Ensure that...

  • Quality Assurance Specialist

    1 month ago

    india Carnivore Style Full time

    Carnivore Style – Your #1 Resource On All Things Meat-Related – is looking for a Quality Assurance Specialist! Join us – salary ranges from $6,000 to $7,500 per month, plus other perks and benefits.  If you want to know more about what we do (and what you will be doing), visit our website’s page and check out our online community of meat lovers!...

  • Quality Assurance Specialist

    1 week ago

    India Carnivore Style Full time

    Carnivore Style – Your #1 Resource On All Things Meat-Related – is looking for a Quality Assurance Specialist Join us – salary ranges from $6,000 to $7,500 per month, plus other perks and benefits. If you want to know more about what we do (and what you will be doing), visit our website's page and check out our online community of meat lovers The Role...

  • Quality Assurance Specialist

    3 weeks ago

    india Carnivore Style Full time

    Carnivore Style – Your #1 Resource On All Things Meat-Related – is looking for a Quality Assurance Specialist! Join us – salary ranges from $6,000 to $7,500 per month, plus other perks and benefits.  If you want to know more about what we do (and what you will be doing), visit our website’s page and check out our online community of meat lovers!...

  • Quality Specialist

    1 week ago

    India PSC Biotech Ltd Full time

    Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • Business Intelligence Manager

    3 weeks ago

    india ScS - Sofa Carpet Specialist Full time

    Department IT Employment Type Full Time Location Sunderland - Customer Support Centre Workplace type Hybrid Compensation £, / year Reporting To Head of Business Reporting What does the role involve? Who are we looking for? What’s in it for you? About ScS – Sofa Carpet Specialist We are one of the UK’s...

  • Business Intelligence Manager

    2 months ago

    india ScS - Sofa Carpet Specialist Full time

    Department IT Employment Type Full Time Location Sunderland - Customer Support Centre Workplace type Hybrid Compensation £, / year Reporting To Head of Business Reporting What does the role involve? Who are we looking for? What’s in it for you? About ScS – Sofa Carpet Specialist We are one of the UK’s...

  • Quality Assurance Specialist

    1 week ago

    India VE3 Full time

    Job Description Position Title: Quality Assurance Specialist Location: United Kingdom Reports To: Programme Director Position Type: Full-time Experience Level: 5+ years. About the Company: We leverage our strong capabilities to build powerful solutions that make a real difference to our clients. We offer a full lifecycle approach to our services, from...

  • Senior Quality Assurance Specialist

    1 day ago

    india Expertiqo Full time

    Join Our Team as a Quality Assurance Specialist – Salesforce Commerce Cloud Are you ready to be at the forefront of digital innovation, ensuring seamless customer experiences globally? We are seeking a dynamic individual to join our team as a Quality Assurance Specialist for our digital platforms. If you are passionate about maximizing features and...

  • Business Intelligence Manager

    2 months ago

    Northeast India ScS - Sofa Carpet Specialist Full time

    Department IT Employment Type Full Time Location Sunderland - Customer Support Centre Workplace type Hybrid Compensation £, / year Reporting To Head of Business Reporting What does the role involve? Who are we looking for? What’s in it for you? About ScS – Sofa Carpet Specialist We are one of the UK’s leading sofa and...

  • Business Intelligence Manager

    3 weeks ago

    Northeast India ScS - Sofa Carpet Specialist Full time

    Department IT Employment Type Full Time Location Sunderland - Customer Support Centre Workplace type Hybrid Compensation £, / year Reporting To Head of Business Reporting What does the role involve? Who are we looking for? What’s in it for you? About ScS – Sofa Carpet Specialist We are one of the UK’s leading sofa and...

  • Quality Assurance Specialist 1x

    4 weeks ago

    india Booth and Partners Pte Ltd Full time

    Job Description Monitor and evaluate call center interactions, including inbound and outbound calls, emails, and chat sessions, to ensure adherence to company policies, procedures, and quality standards. ●  Conduct regular audits and assessments of call center agents' performance, providing constructive feedback and coaching to improve patient service...

  • Quality Assurance Specialist 1x

    3 weeks ago

    india Booth and Partners Pte Ltd Full time

    Job Description Monitor and evaluate call center interactions, including inbound and outbound calls, emails, and chat sessions, to ensure adherence to company policies, procedures, and quality standards. ●  Conduct regular audits and assessments of call center agents' performance, providing constructive feedback and coaching to improve patient service...

  • HR Data Quality Specialist

    4 weeks ago

    india Bee Talent Solutions Full time

    We are looking for an experienced HR Data Quality Specialist for our client in India. You’ll play a critical role in delivering HR reporting support in Workday and ServiceNow to ensure accuracy of data in Workday while managing the daily responsibilities of a team of global People Operations Specialists. The role will support the People Operations Team...

  • HR Data Quality Specialist

    4 weeks ago

    India Bee Talent Solutions Full time

    We are looking for an experienced HR Data Quality Specialist for our client in India. You’ll play a critical role in delivering HR reporting support in Workday and ServiceNow to ensure accuracy of data in Workday while managing the daily responsibilities of a team of global People Operations Specialists. The role will support the People Operations Team...