Location: Ahmedabad
Experience: 5 to 8 years
Qualification: B.Sc Chemistry
Position Summary :This role defines the complete handling and monitoring of IPQA activities, which includes management of in-process controls from start of dispensing till he completion of dispatch of the product from the facility. The IPQA team member should have proficient knowledge of batch manufacturing and packing operation per the regulatory, excipact and ISO requirements. This role is will have extended responsibility in product release, registration and new product development and launches related to Quality responsibility.
About Actylis:Over the last 70 years, Actylis has established itself as a leading value-added global chemical supplier specializing in specialty chemicals, nutritional ingredients, and products used across the pharmaceutical value chain including reagents and process aids, intermediates, APIs, and excipients. Actylis’ operations span ten countries including the US, Canada, China, India, France, Germany, Netherlands, Ireland, and Singapore. Our global network and staff specialize in 6 core competencies, viz. R&D, Production, Quality Assurance, Supply Chain, Global Sourcing, and Regulatory Compliance. This set of competencies enable agility and choice for our customers, so that they can more rapidly develop and commercialize their innovative products and supply them dependably to their customers.
Key Duties & Responsibilities : :
To provide line clearance while executing operational activities for different departments like but not limited to – warehouse, liquid production, solid production, PR-03 area, packaging area, dispatch area etc.
To review and approve Label content while packaging operation.
To review all routine logbooks and records for all manufacturing and operational activities.
To review the packaging record and batch manufacturing records for their completeness and correctness.
To prepare and review process validation protocol and reports.
To issue and maintain batch manufacturing record documents.
To be responsible for batch release of finished products.
To be part of process approver and verifier as quality assurance representative for dispatch of goods from facility.
To document and manage the return goods and further operation activity.
To monitor and ensure the calibration and preventive maintenance activity completion and proper tagging for all the equipment and instrument utilized in batch manufacturing, packing, and handling activity.
To be part of SOP preparation and review for QA department and act as a reviewer for the SOP of cross functional department.
Preparation and review of process validation protocol and reports.
Management of control sample for Pharma Finished products.
Management of customer samples and handling of customer sample request.
To be part of change control review process for all cross functional change control and part of investigation pertaining to and not limited to Deviation, Market complaint, nonconformance etc. where operations related investigation inputs and involvement needed.
Education :
B.Sc / M.Sc in Chemistry
Experience :
10 years of experience in Pharmaceutical, API or excipient regulated industries.
Competencies & Skillset :
Supervisory Responsibilities: Yes / No
