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Torrent Pharma (Malta) Limited

&lt;p&gt;We are currently looking for an &lt;strong&gt;Analytical Quality Assurance Officer&lt;/strong&gt; to join our team.&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;As an AQA Officer, you will play a pivotal role in upholding our commitment to quality and compliance. You will collaborate with a cross-functional team to ensure that all analytical activities adhere to GMP standards, company procedures, and regulatory guidelines.&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Key Responsibilities:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Manage day-to-day Analytical Quality Assurance activities, ensuring strict adherence to GMP directives and guidelines&lt;/li&gt;
&lt;li&gt;Prepare, review, and approve analytical worksheets, LIMS Master data, protocols, SOPs, and reports&lt;/li&gt;
&lt;li&gt;Coordinate analytical method transfers, including comprehensive documentation review&lt;/li&gt;
&lt;li&gt;Investigate out-of-specification results and laboratory deviations, driving root cause analysis and corrective actions&lt;/li&gt;
&lt;li&gt;Review and approve instrument calibration, qualification, and analytical data, ensuring accuracy and reliability&lt;/li&gt;
&lt;li&gt;Collaborate with internal and external stakeholders to maintain a robust quality system&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Job Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree or diploma in a scientific field (Chemistry, Pharmacy, or related discipline)&lt;/li&gt;
&lt;li&gt;Minimum of 2 years of experience in pharmaceutical quality assurance or a related field&lt;/li&gt;
&lt;li&gt;Demonstrated expertise in GMP principles and regulatory requirements&lt;/li&gt;
&lt;li&gt;Strong analytical skills and meticulous attention to detail&lt;/li&gt;
&lt;li&gt;Excellent communication and interpersonal skills, with fluency in English (both written and verbal)&lt;/li&gt;
&lt;li&gt;Proactive, results-oriented, and capable of working independently and as part of a team&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What we offer:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Competitive remuneration package&lt;/li&gt;
&lt;li&gt;Comprehensive health insurance&lt;/li&gt;
&lt;li&gt;Continuous professional growth opportunities in a state-of-the-art laboratory equipped with the latest technologies&lt;/li&gt;
&lt;/ul&gt;

Analytical Quality Assurance Officer

&lt;p&gt;We are looking for a motivated and experienced &lt;strong&gt;Senior QC Analyst&lt;/strong&gt; to join our growing team. In this role, you will work in a GMP-compliant chemistry laboratory, where your expertise will directly contribute to delivering high-quality finished products.&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Key Responsibilities:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Prepare, standardise and label stock solutions and laboratory reagents as required.&lt;/li&gt;
&lt;li&gt;Perform finished product and purified water testing using approved methods and specifications.&lt;/li&gt;
&lt;li&gt;Ensure proper handling, qualification, and calibration of laboratory equipment, including supporting external contractors and maintaining accurate records.&lt;/li&gt;
&lt;li&gt;Maintain and review QC documentation, SOPs, logs, and registers to ensure ongoing compliance.&lt;/li&gt;
&lt;li&gt;Support QC investigations, including deviations, OOX results, and change controls, and where required provide guidance to junior analysts.&lt;/li&gt;
&lt;li&gt;Carry out other Quality Control-related duties as required.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Job Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree or diploma in a scientific field.&lt;/li&gt;
&lt;li&gt;Minimum of 3 years of experience in a pharmaceutical QC laboratory, with strong expertise in chromatographic techniques.&lt;/li&gt;
&lt;li&gt;Excellent attention to detail, well-organised, and able to prioritise tasks effectively.&lt;/li&gt;
&lt;li&gt;Excellent communication skills.&lt;/li&gt;
&lt;li&gt;Valid work permit.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What we offer:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Competitive remuneration package with regular reviews and salary progression.&lt;/li&gt;
&lt;li&gt;Continuous professional development opportunities in a state-of-the-art, brand-new laboratory equipped with the latest technologies.&lt;/li&gt;
&lt;li&gt;Comprehensive health insurance.&lt;/li&gt;
&lt;/ul&gt;

Senior Quality Control Analyst

&lt;p&gt;We are seeking an experienced &lt;strong&gt;Regulatory Affairs Specialist&lt;/strong&gt; to support our growing EU Regulatory Affairs function.&lt;/p&gt;
&lt;p&gt;This role is focused on EU post-authorisation lifecycle management, including safety-related and CMC-related regulatory activities.&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Key Responsibilities:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Prepare, review and support EU lifecycle submissions, including Type IA, IAIN, IB and Type II variations.&lt;/li&gt;
&lt;li&gt;Support variation classification, grouping, worksharing, implementation dates and submission planning.&lt;/li&gt;
&lt;li&gt;Support safety-related lifecycle updates, including Product Information updates, RMP-related changes, PSUR outcomes, referrals and reference product updates.&lt;/li&gt;
&lt;li&gt;Support CMC lifecycle changes, including manufacturing site changes, analytical methods, specifications, stability, suppliers, packaging, batch release and testing sites.&lt;/li&gt;
&lt;li&gt;Prepare, review and coordinate SmPC, labelling and package leaflet updates.&lt;/li&gt;
&lt;li&gt;Support renewals, regulatory commitments and lifecycle tracking activities.&lt;/li&gt;
&lt;li&gt;Prepare and support responses to authority questions, validation issues and clock-stops.&lt;/li&gt;
&lt;li&gt;Liaise with corporate RA teams, internal departments, external partners, consultants and regulatory authorities.&lt;/li&gt;
&lt;li&gt;Maintain RA trackers, submission plans and regulatory documentation.&lt;/li&gt;
&lt;li&gt;Contribute to the development of RA procedures, templates and working practices.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Chemistry or related discipline.&lt;/li&gt;
&lt;li&gt;Minimum 5 years’ Regulatory Affairs experience within the pharmaceutical industry.&lt;/li&gt;
&lt;li&gt;Hands-on experience in EU post-authorisation lifecycle management.&lt;/li&gt;
&lt;li&gt;Experience with safety-related and/or CMC-related variations.&lt;/li&gt;
&lt;li&gt;Good knowledge of DCP, MRP and national procedures.&lt;/li&gt;
&lt;li&gt;Understanding of EU variation requirements, CMDh/HMA guidance, eAF requirements and regulatory submission processes.&lt;/li&gt;
&lt;li&gt;Ability to review regulatory documentation and identify gaps before submission.&lt;/li&gt;
&lt;li&gt;Excellent organisational, communication and problem-solving skills.&lt;/li&gt;
&lt;li&gt;Fluent written and spoken English.&lt;/li&gt;
&lt;li&gt;Eligibility to work in Malta / EU.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Preferred Experience:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Experience with generic medicinal products.&lt;/li&gt;
&lt;li&gt;Experience with multi-country EU regulatory portfolios.&lt;/li&gt;
&lt;li&gt;Experience with eCTD lifecycle submissions and electronic submission systems.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What We Offer:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Competitive remuneration package.&lt;/li&gt;
&lt;li&gt;Comprehensive health insurance.&lt;/li&gt;
&lt;li&gt;Professional development and training opportunities.&lt;/li&gt;
&lt;li&gt;Exposure to a broad European pharmaceutical portfolio.&lt;/li&gt;
&lt;li&gt;Opportunity to contribute to the development of a growing EU Regulatory Affairs function in Malta.&lt;/li&gt;
&lt;/ul&gt;

Regulatory Affairs Specialist – EU Lifecycle Management

&lt;p&gt;We are looking for a highly experienced &lt;strong&gt;Deputy Regulatory Affairs Manager - EU Lifecycle Management&lt;/strong&gt; to support our growing EU Regulatory Affairs function.&lt;/p&gt;
&lt;p&gt;This is a senior, hands-on role focused on EU post-authorisation lifecycle management, including safety-related and CMC-related regulatory activities.&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Key Responsibilities:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Manage and support EU lifecycle submissions, including Type IA, IAIN, IB and Type II variations.&lt;/li&gt;
&lt;li&gt;Provide regulatory strategy for variation classification, grouping, work-sharing, implementation dates and submission planning.&lt;/li&gt;
&lt;li&gt;Support safety-related lifecycle updates, including Product Information updates, RMP-related changes, PSUR outcomes, referrals and reference product updates.&lt;/li&gt;
&lt;li&gt;Support CMC lifecycle changes, including manufacturing site changes, analytical methods, specifications, stability, suppliers, packaging, batch release and testing sites.&lt;/li&gt;
&lt;li&gt;Prepare, review and coordinate SmPC, labelling and package leaflet updates.&lt;/li&gt;
&lt;li&gt;Support responses to authority questions, validation issues and clock-stops.&lt;/li&gt;
&lt;li&gt;Liaise with corporate RA teams, internal departments, external partners, consultants and regulatory authorities.&lt;/li&gt;
&lt;li&gt;Mentor RA team members and support development of RA procedures, trackers and working practices.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Chemistry or related discipline.&lt;/li&gt;
&lt;li&gt;Minimum 10 years’ Regulatory Affairs experience within the pharmaceutical industry.&lt;/li&gt;
&lt;li&gt;Strong hands-on experience in EU post-authorisation lifecycle management.&lt;/li&gt;
&lt;li&gt;Experience with both safety-related and CMC-related variations.&lt;/li&gt;
&lt;li&gt;Good knowledge of DCP, MRP and national procedures.&lt;/li&gt;
&lt;li&gt;Strong understanding of EU variation requirements, CMDh/HMA guidance, eAF requirements and regulatory submission processes.&lt;/li&gt;
&lt;li&gt;Experience reviewing submissions and identifying regulatory gaps before filing.&lt;/li&gt;
&lt;li&gt;Excellent organisational, communication and problem-solving skills.&lt;/li&gt;
&lt;li&gt;Fluent written and spoken English.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Preferred Experience:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Experience with generic medicinal products.&lt;/li&gt;
&lt;li&gt;Experience with multi-country EU regulatory portfolios.&lt;/li&gt;
&lt;li&gt;Experience with eCTD lifecycle submissions and electronic submission systems.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What We Offer:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Competitive remuneration package.&lt;/li&gt;
&lt;li&gt;Comprehensive health insurance.&lt;/li&gt;
&lt;li&gt;Professional development and training opportunities.&lt;/li&gt;
&lt;li&gt;Exposure to a broad European pharmaceutical portfolio.&lt;/li&gt;
&lt;li&gt;Opportunity to contribute to the development of a growing EU Regulatory Affairs function in Malta.&lt;/li&gt;
&lt;/ul&gt;

There Are No Job Openings at Torrent Pharma (Malta) Limited At The Moment