QA Technician

Job content

Job Description

Key Roles and Responsibilities:

• Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures and Analytical Procedures.
• Participate in quality related investigations, assist in the development and approval of effective CAPA in order to resolve production, audit and customer issues.
• Identify and escalate any identified cGMP areas of concern.
• Participate in validation activities including approval of protocols and reports for analytical methods, manufacturing processes, analytical / production / packaging equipment and cleaning procedures
• Participate in the audits of suppliers, production and support functions as required.
• Be involved in the preparation for MHRA/FDA and other regulatory body audits.
• Review the relevant documentation relating to incoming raw materials and perform the disposition activities as required.
• Reviewing manufacturing, laboratory and associated documentation prior to performing the relevant disposition of final products. Where potential issues exist, these are to be highlighted to the QA manager.
• Act as the QA representative for the introduction of new products, being a key member of the multi-functional team including R&D, QC and manufacturing thus ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.
  
  

Key Competencies

• Attention to detail
• Good communication skills, both verbal and written
• Good organisation skills
• Ability to work effectively individually and as part of a team
• Ability to analyse data and information to make considered decisions
• The ability to identify root cause of problems to determine appropriate solutions
• Ability to prioritise workload to ensure timelines are met
• Ability to follow instruction accurately
• Ability to escalate issues as appropriate
  
  

Qualifications

Essential Qualification:

BSc in a relevant Scientific discipline or equivalent.

Relevant Experience

• A minimum of 3 years’ experience within a cGMP environment manufacturing Active Pharmaceutical Ingredients is required.
• A College/University qualification in a scientific subject is required.
• Experience in dealing with quality assurance, analytical chemistry, development, and manufacturing groups is beneficial
  
  

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.